Nutritional Deficiency, Vitamin D Deficiency
Conditions
Keywords
Vitamin D
Brief summary
The overall goal of this study is to assess maternal vitamin D status along with diet, and milk composition, and in turn, to evaluate if infant vitamin D status can be improved with increased maternal supplementation and diet education. The central hypothesis is that by maximizing maternal vitamin D status in breastfed, preterm infants (\<35 weeks), there will be an increase infant 25(OH)D status at 1,2, and 3 months of age.
Interventions
DRUGHigh dose Cholecalciferol
Mothers in experimental group will receive 6,000 IU of vitamin D in addition to their prenatal vitamin, daily for 3 months. Infants in this group will receive placebo vitamin D drops
DRUGCholecalciferol
Mothers in placebo control group will receive 600 IU of vitamin D in the form of their prenatal vitamin along with placebo vitamin D. Infants of the mothers in this group will receive standard 400 IU of vitamin D
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Days to 45 Years
Healthy volunteers
No
Inclusion criteria
* Women with documentation of fully breastfeeding who present within one month of delivery, who are 18-45 years old and in good general health will be eligible for participation. * Infants \<35 weeks corrected gestational age at birth
Exclusion criteria
* NO DMI/DMII, HTN, or parathyroid disease IF thyroid issues, currently euthyroid * Multiple gestations * No liver disease * No major congenital abnormalities * No kidney disease * No inborn errors of metabolism * No parathyroid disease * No disorders of calcium metabolism * No antiepileptics * No steroids * No congenital heart disease * No severe illness at birth deemed incompatible with survival
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Mothers With Elevated Calcium Concentrations at Month 3 | 3 months post enrollment | Number of mothers with serum calcium \> 10.5 mg/dL |
| Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 1 | 1 month post enrollment | Number of mothers with serum calcium \> 1.0 mmol/mmol |
| Number of Infants With Sufficient 25(OH)D Stores at 3 Months | 3 months post enrollment | Number of infants with 25(OH)D levels \> 20 ng/mL |
| Number of Mothers With Sufficient 25(OH)D Stores at 3 Months | 3 months post enrollment | Number of mothers with 25(OH)D levels \>20 ng/mL |
| Number of Mothers With Elevated Calcium Concentrations at 1 Month | 1 month post enrollment | Number of mothers with serum calcium \> 10.5 mg/dL |
| Number of Mothers With Elevated Calcium Concentrations at Month 2 | 2 months post enrollment | Number of mothers with serum calcium \> 10.5 mg/dL |
| Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 2 | 2 months post enrollment | Number of mothers with urine calcium/creatinine ratio \> 1.0 mmol/mmol |
| Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 3 | 3 months post enrollment | Number of mothers with urine calcium/creatinine ratio \> 1.0 mmol/mmol |
| Number of Infants With Elevated Calcium Concentration at Month 1 | 1 month post enrollment | Number of infants with serum calcium \> 11.0 mg/dL |
| Number of Infants With Elevated Calcium Concentration at Month 2 | 2 months post enrollment | Number of infants with serum calcium \> 11.0 mg/dL |
| Number of Infants With Elevated Calcium Concentration at Month 3 | 3 months post enrollment | Number of infants with serum calcium \> 11.0 mg/dL |
Countries
United States
Participant flow
Recruitment details
This study contained dyads of mother's and their newborn infants. Double-blinded control randomized study
Pre-assignment details
This study involves mother and infant dyads. There were 8 individual participants enrolled onto the study. 4 mothers and 4 infants which is equivalent to 4 dyads. Group A had 2 dyads (4 individual participants). Group B also had 2 dyads (4 individual participants) However, if an infant became ineligible but mother still qualified, she could remain in the study separately. The participant flow reflects the individual participants.
Participants by arm
| Arm | Count |
|---|---|
| Group A High dose Cholecalciferol: Mothers in experimental group will receive 6,000 IU of vitamin D in addition to their prenatal vitamin, daily for 3 months. | 4 |
| Group B Cholecalciferol: Mothers in placebo control group will receive 600 IU of vitamin D in the form of their prenatal vitamin along with placebo vitamin D. | 4 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 2 |
Baseline characteristics
| Characteristic | Group A | Total | Group B |
|---|---|---|---|
| Age, Continuous Mothers | 28.5 years | 27 years | 24.5 years |
| Age, Customized Infants | 28.5 weeks | 29.25 weeks | 30 weeks |
| Race (NIH/OMB) Infants American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Infants Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Infants Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Infants More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Infants Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Infants Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Infants White | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Mothers American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Mothers Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Mothers Black or African American | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Mothers More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Mothers Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Mothers Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Mothers White | 1 Participants | 2 Participants | 1 Participants |
| Region of Enrollment United States | 4 participants | 8 participants | 4 participants |
| Sex: Female, Male Infants Female | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Infants Male | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Mothers Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Mothers 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 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
Primary
Number of Infants With Elevated Calcium Concentration at Month 1
Number of infants with serum calcium \> 11.0 mg/dL
Time frame: 1 month post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Number of Infants With Elevated Calcium Concentration at Month 1 | 0 Participants |
| Group B | Number of Infants With Elevated Calcium Concentration at Month 1 | 0 Participants |
Primary
Number of Infants With Elevated Calcium Concentration at Month 2
Number of infants with serum calcium \> 11.0 mg/dL
Time frame: 2 months post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Number of Infants With Elevated Calcium Concentration at Month 2 | 0 Participants |
| Group B | Number of Infants With Elevated Calcium Concentration at Month 2 | 0 Participants |
Primary
Number of Infants With Elevated Calcium Concentration at Month 3
Number of infants with serum calcium \> 11.0 mg/dL
Time frame: 3 months post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Number of Infants With Elevated Calcium Concentration at Month 3 | 0 Participants |
| Group B | Number of Infants With Elevated Calcium Concentration at Month 3 | 0 Participants |
Primary
Number of Infants With Sufficient 25(OH)D Stores at 3 Months
Number of infants with 25(OH)D levels \> 20 ng/mL
Time frame: 3 months post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Number of Infants With Sufficient 25(OH)D Stores at 3 Months | 1 Participants |
| Group B | Number of Infants With Sufficient 25(OH)D Stores at 3 Months | 1 Participants |
Primary
Number of Mothers With Elevated Calcium Concentrations at 1 Month
Number of mothers with serum calcium \> 10.5 mg/dL
Time frame: 1 month post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Number of Mothers With Elevated Calcium Concentrations at 1 Month | 0 Participants |
| Group B | Number of Mothers With Elevated Calcium Concentrations at 1 Month | 0 Participants |
Primary
Number of Mothers With Elevated Calcium Concentrations at Month 2
Number of mothers with serum calcium \> 10.5 mg/dL
Time frame: 2 months post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Number of Mothers With Elevated Calcium Concentrations at Month 2 | 0 Participants |
| Group B | Number of Mothers With Elevated Calcium Concentrations at Month 2 | 0 Participants |
Primary
Number of Mothers With Elevated Calcium Concentrations at Month 3
Number of mothers with serum calcium \> 10.5 mg/dL
Time frame: 3 months post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Number of Mothers With Elevated Calcium Concentrations at Month 3 | 0 Participants |
| Group B | Number of Mothers With Elevated Calcium Concentrations at Month 3 | 0 Participants |
Primary
Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 1
Number of mothers with serum calcium \> 1.0 mmol/mmol
Time frame: 1 month post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 1 | 0 Participants |
| Group B | Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 1 | 0 Participants |
Primary
Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 2
Number of mothers with urine calcium/creatinine ratio \> 1.0 mmol/mmol
Time frame: 2 months post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 2 | 0 Participants |
| Group B | Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 2 | 0 Participants |
Primary
Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 3
Number of mothers with urine calcium/creatinine ratio \> 1.0 mmol/mmol
Time frame: 3 months post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 3 | 0 Participants |
| Group B | Number of Mothers With Elevated Urine Calcium Creatinine Ratio at Month 3 | 0 Participants |
Primary
Number of Mothers With Sufficient 25(OH)D Stores at 3 Months
Number of mothers with 25(OH)D levels \>20 ng/mL
Time frame: 3 months post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Group A | Number of Mothers With Sufficient 25(OH)D Stores at 3 Months | 1 Participants |
| Group B | Number of Mothers With Sufficient 25(OH)D Stores at 3 Months | 1 Participants |