Bisphenol Exposure, Phthalate Exposure
Conditions
Brief summary
Phthalates and bisphenols have been detected in a range of infant care products. This pilot study will test whether intervening on these sources of exposure during the critical period of minipuberty affects infants' body burden of phthalates and bisphenols. Investigators will recruit 10 participants from the ongoing NYU Children's Health and Development Study (CHES) cohort study who are \>=37 weeks gestation, carrying a male fetus, and intending to breastfeed. Investigators will randomly assign them to use either conventional baby products or phthalate- and bisphenol-free baby products for the first three months of their children's lives. Toward the end of the intervention, investigators will collect maternal breast milk and infant urine, and assay samples for phthalate metabolite and bisphenol concentrations.
Interventions
OTHERPhthalate- and Bisphenol-free Baby Products
3-month supply. Products include wipes and diaper cream.
OTHERCloth Diapers
Subscription to cloth diaper service.
OTHERConventional Disposable Diapers
3-month supply.
OTHERConventional Baby Products
Products include wipes and diaper cream.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Enrolled in NYU CHES study at the NYULH-Brooklyn campus 2. 18 years of age or older 3. At least 37 weeks gestation 4. Carrying a male singleton fetus 5. Intending to breastfeed 6. English or Spanish speaking 7. Intending for pediatric care for infant to occur at the Sunset Park Family Health Center at NYU Langone
Exclusion criteria
1. Not enrolled in NYU CHES study from the NYULH-Brooklyn campus 2. Under 37 weeks gestation 3. Carrying a female fetus 4. Carrying multiples 5. Not intending to breastfeed 6. Not comfortable communicating in English or Spanish 7. Not intending for pediatric care for infant to occur at NYULH Sunset Park Family Health Center 8. Under 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Log Signal Intensity of Bisphenol A (BPA) in Child Urine Samples | Month 3 | Child urine samples were analyzed for bisphenols and for phthalate metabolites via non-targeted HPLC-MS/MS. The log signal intensity, an arbitrary unit, is a measurement of the signal strength of BPA in child urine; as the concentration of BPA increases, the signal intensity increases proportionally in a logarithmic fashion; higher values indicate greater infant exposure to bisphenol. |
| Log Signal Intensity of Bisphenol A (BPA) in Maternal Urine Samples | Month 3 | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via non-targeted HPLC-MS/MS. The log signal intensity, an arbitrary unit, is a measurement of the signal strength of BPA in child urine; as the concentration of BPA increases, the signal intensity increases proportionally in a logarithmic fashion; higher values indicate greater maternal exposure to bisphenol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Concentrations of Monomethyl Phthalate (mMP) in Maternal Urine Samples | Month 3 | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Monoethyl Phthalate (mEP) in Child Urine Samples | Month 3 | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Monoethyl Phthalate (mEP) in Maternal Urine Samples | Month 3 | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Phthalic Acid (PA) in Child Urine Samples | Month 3 | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Phthalic Acid (PA) in Maternal Urine Samples | Month 3 | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Child Urine Samples | Month 3 | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Child Urine Samples | Month 3 | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Maternal Urine Samples | Month 3 | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Monobutyl Phthalate (mBP) in Child Urine Samples | Month 3 | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Monobutyl Phthalate (mBP) in Maternal Urine Samples | Month 3 | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Maternal Urine Samples | Month 3 | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Maternal Urine Samples | Month 3 | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Child Urine Samples | Month 3 | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Maternal Urine Samples | Month 3 | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Child Urine Samples | Month 3 | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Maternal Urine Samples | Month 3 | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Bisphenol S (BPS) in Child Urine Samples | Month 3 | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Bisphenol S (BPS) in Maternal Urine Samples | Month 3 | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Mono-carboxy-isononyl Phthalate (mCINP) in Maternal Urine Samples | Month 3 | Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Ono-carboxy-isononyl Phthalate (mCINP) in Child Urine Samples | Month 3 | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Child Urine Samples | Month 3 | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
| Mean Concentrations of Monomethyl Phthalate (mMP) in Child Urine Samples | Month 3 | Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS. |
Countries
United States
Participant flow
Pre-assignment details
Infants were not considered enrolled participants for the purpose of this study; infant urine samples were submitted voluntarily by enrolled (mother) participants at home during follow-up. Participant information (participant flow, baseline characteristics) are thus not reported for infants.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Half of the participants will be randomly assigned to the intervention group and will receive a three-month supply of phthalate- and bisphenol-free baby products (e.g., wipes, diaper cream) and a subscription to a cloth diaper service. Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Phthalate- and Bisphenol-free Baby Products: 3-month supply. Products include wipes and diaper cream.
Cloth Diapers: Subscription to cloth diaper service. | 3 |
| Control Group Half of the participants will be randomly assigned to the control group and provided with a three-month supply of conventional disposable diapers (e.g., Huggies or Pampers) and baby products (e.g., wipes, diaper cream). Participants will be contacted after 2 and 6 weeks over the phone and administered a brief adherence survey.
Conventional Disposable Diapers: 3-month supply.
Conventional Baby Products: Products include wipes and diaper cream. | 2 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 3 |
Baseline characteristics
| Characteristic | Intervention Group | Total | Control Group |
|---|---|---|---|
| Age, Continuous | 27.02 years STANDARD_DEVIATION 3.96 | 30.023 years STANDARD_DEVIATION 8.58 | 33.025 years STANDARD_DEVIATION 13.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 3 participants | 5 participants | 2 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 0 / 5 | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 |
Outcome results
Primary
Log Signal Intensity of Bisphenol A (BPA) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via non-targeted HPLC-MS/MS. The log signal intensity, an arbitrary unit, is a measurement of the signal strength of BPA in child urine; as the concentration of BPA increases, the signal intensity increases proportionally in a logarithmic fashion; higher values indicate greater infant exposure to bisphenol.
Time frame: Month 3
Population: 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Log Signal Intensity of Bisphenol A (BPA) in Child Urine Samples | 0.00 Log(Arbitrary Units) | Standard Deviation 0 |
| Control Group | Log Signal Intensity of Bisphenol A (BPA) in Child Urine Samples | 5.43 Log(Arbitrary Units) | Standard Deviation 0.16 |
Primary
Log Signal Intensity of Bisphenol A (BPA) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via non-targeted HPLC-MS/MS. The log signal intensity, an arbitrary unit, is a measurement of the signal strength of BPA in child urine; as the concentration of BPA increases, the signal intensity increases proportionally in a logarithmic fashion; higher values indicate greater maternal exposure to bisphenol.
Time frame: Month 3
Population: 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Log Signal Intensity of Bisphenol A (BPA) in Maternal Urine Samples | 3.49 Log(Arbitrary Units) | Standard Deviation 2.47 |
| Control Group | Log Signal Intensity of Bisphenol A (BPA) in Maternal Urine Samples | 4.74 Log(Arbitrary Units) | Standard Deviation 0.4 |
Secondary
Mean Concentrations of Bisphenol S (BPS) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: Only one intervention and one control sample was collected for child urine
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Mean Concentrations of Bisphenol S (BPS) in Child Urine Samples | 2.09 microgram/gram creatinine |
| Control Group | Mean Concentrations of Bisphenol S (BPS) in Child Urine Samples | 1.61 microgram/gram creatinine |
Secondary
Mean Concentrations of Bisphenol S (BPS) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: 2 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Mean Concentrations of Bisphenol S (BPS) in Maternal Urine Samples | 1.80 microgram/gram creatinine | Standard Deviation 0.82 |
| Control Group | Mean Concentrations of Bisphenol S (BPS) in Maternal Urine Samples | 0.57 microgram/gram creatinine | Standard Deviation 0.58 |
Secondary
Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: Only one intervention and one control sample was collected for child urine
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Child Urine Samples | 0.42 microgram/gram creatinine |
| Control Group | Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Child Urine Samples | 6.81 microgram/gram creatinine |
Secondary
Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Maternal Urine Samples | 8.15 microgram/gram creatinine | Standard Deviation 7.19 |
| Control Group | Mean Concentrations of Mono-(2-ethyl-5-hydroxyhexyl) Phthalate (mEHHP) in Maternal Urine Samples | 2.43 microgram/gram creatinine | Standard Deviation 0.98 |
Secondary
Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: Only one intervention and one control sample was collected for child urine
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Child Urine Samples | 0.39 microgram/gram creatinine |
| Control Group | Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Child Urine Samples | 5.06 microgram/gram creatinine |
Secondary
Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Maternal Urine Samples | 4.34 microgram/gram creatinine | Standard Deviation 3.16 |
| Control Group | Mean Concentrations of Mono-(2-ethyl-5-oxohexyl) Phthalate (mEOHP) in Maternal Urine Samples | 1.37 microgram/gram creatinine | Standard Deviation 0.49 |
Secondary
Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: Only one intervention and one control sample was collected for child urine
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Child Urine Samples | 2.51 microgram/gram creatinine |
| Control Group | Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Child Urine Samples | 20.00 microgram/gram creatinine |
Secondary
Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Maternal Urine Samples | 8.27 microgram/gram creatinine | Standard Deviation 6.6 |
| Control Group | Mean Concentrations of Mono(5-carboxy-2-ethylpentyl) Phthalate (mECPP) in Maternal Urine Samples | 3.06 microgram/gram creatinine | Standard Deviation 0.58 |
Secondary
Mean Concentrations of Monobutyl Phthalate (mBP) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: Only one intervention and one control sample was collected for child urine.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Mean Concentrations of Monobutyl Phthalate (mBP) in Child Urine Samples | 62.77 microgram/gram creatinine |
| Control Group | Mean Concentrations of Monobutyl Phthalate (mBP) in Child Urine Samples | 37.40 microgram/gram creatinine |
Secondary
Mean Concentrations of Monobutyl Phthalate (mBP) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Mean Concentrations of Monobutyl Phthalate (mBP) in Maternal Urine Samples | 18.02 microgram/gram creatinine | Standard Deviation 7.21 |
| Control Group | Mean Concentrations of Monobutyl Phthalate (mBP) in Maternal Urine Samples | 21.75 microgram/gram creatinine | Standard Deviation 19.88 |
Secondary
Mean Concentrations of Mono-carboxy-isononyl Phthalate (mCINP) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: 2 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Mean Concentrations of Mono-carboxy-isononyl Phthalate (mCINP) in Maternal Urine Samples | 0.59 microgram/gram creatinine | Standard Deviation 0.31 |
| Control Group | Mean Concentrations of Mono-carboxy-isononyl Phthalate (mCINP) in Maternal Urine Samples | 1.52 microgram/gram creatinine | Standard Deviation 1.92 |
Secondary
Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: 3 out of 5 participants in the intervention group anf 2 out of 5 in the control group were analyzed as the rest did not provide samples
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Child Urine Samples | 0.50 microgram/gram creatinine |
| Control Group | Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Child Urine Samples | 2.92 microgram/gram creatinine |
Secondary
Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Maternal Urine Samples | 1.90 microgram/gram creatinine | Standard Deviation 1.25 |
| Control Group | Mean Concentrations of Mono-carboxy-isooctyl Phthalate (mCIOP) in Maternal Urine Samples | 2.12 microgram/gram creatinine | Standard Deviation 1.08 |
Secondary
Mean Concentrations of Monoethyl Phthalate (mEP) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: Only one intervention and one control sample was collected for child urine
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Mean Concentrations of Monoethyl Phthalate (mEP) in Child Urine Samples | 129.68 microgram/gram creatinine |
| Control Group | Mean Concentrations of Monoethyl Phthalate (mEP) in Child Urine Samples | 1649.72 microgram/gram creatinine |
Secondary
Mean Concentrations of Monoethyl Phthalate (mEP) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Mean Concentrations of Monoethyl Phthalate (mEP) in Maternal Urine Samples | 89.40 microgram/gram creatinine | Standard Deviation 74.36 |
| Control Group | Mean Concentrations of Monoethyl Phthalate (mEP) in Maternal Urine Samples | 53.30 microgram/gram creatinine | Standard Deviation 8.78 |
Secondary
Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: Only one intervention and one control sample was collected for child urine
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Child Urine Samples | 74.45 microgram/gram creatinine |
| Control Group | Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Child Urine Samples | 28.25 microgram/gram creatinine |
Secondary
Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: 3 out of 5 participants in the intervention group and 2 out of 5 in the control group were analyzed as the rest did not provide samples
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Maternal Urine Samples | 13.07 microgram/gram creatinine | Standard Deviation 10.02 |
| Control Group | Mean Concentrations of Mono-iso-butyl Phthalate (mIBP) in Maternal Urine Samples | 10.12 microgram/gram creatinine | Standard Deviation 7.04 |
Secondary
Mean Concentrations of Monomethyl Phthalate (mMP) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: Only one intervention and one control sample was collected for child urine
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Mean Concentrations of Monomethyl Phthalate (mMP) in Child Urine Samples | 27.23 microgram/gram creatinine |
| Control Group | Mean Concentrations of Monomethyl Phthalate (mMP) in Child Urine Samples | 13.79 microgram/gram creatinine |
Secondary
Mean Concentrations of Monomethyl Phthalate (mMP) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: 3 out of 5 participants in the intervention group anf 2 out of 5 in the control group were analyzed as the rest did not provide samples
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Mean Concentrations of Monomethyl Phthalate (mMP) in Maternal Urine Samples | 2.91 microgram/gram creatinine | Standard Deviation 2.66 |
| Control Group | Mean Concentrations of Monomethyl Phthalate (mMP) in Maternal Urine Samples | 5.10 microgram/gram creatinine | Standard Deviation 0.41 |
Secondary
Mean Concentrations of Ono-carboxy-isononyl Phthalate (mCINP) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: Only one intervention and one control sample was collected for child urine
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Mean Concentrations of Ono-carboxy-isononyl Phthalate (mCINP) in Child Urine Samples | 0.61 microgram/gram creatinine |
| Control Group | Mean Concentrations of Ono-carboxy-isononyl Phthalate (mCINP) in Child Urine Samples | 1.06 microgram/gram creatinine |
Secondary
Mean Concentrations of Phthalic Acid (PA) in Child Urine Samples
Child urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: Only one intervention and one control sample was collected for child urine
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention Group | Mean Concentrations of Phthalic Acid (PA) in Child Urine Samples | 24.18 microgram/gram creatinine |
| Control Group | Mean Concentrations of Phthalic Acid (PA) in Child Urine Samples | 161.58 microgram/gram creatinine |
Secondary
Mean Concentrations of Phthalic Acid (PA) in Maternal Urine Samples
Maternal urine samples were analyzed for bisphenols and for phthalate metabolites via targeted LC-MS/MS.
Time frame: Month 3
Population: 3 out of 5 participants in the intervention group anf 2 out of 5 in the control group were analyzed as the rest did not provide samples
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Group | Mean Concentrations of Phthalic Acid (PA) in Maternal Urine Samples | 63.96 microgram/gram creatinine | Standard Deviation 91.12 |
| Control Group | Mean Concentrations of Phthalic Acid (PA) in Maternal Urine Samples | 211.21 microgram/gram creatinine | Standard Deviation 126.69 |