Growth and Development
Conditions
Brief summary
The present study supplements iron as part of multiple micro-nutrient supplementation to demonstrate that intake of a micronutrient fortified powder in milk helps increase the uptake of key micronutrients like iron due to unique nature of the given matrix, as compared to intake of iron alone in milk.
Interventions
DIETARY_SUPPLEMENTTest
Experimental product: Micronutrient fortified beverage powder, packed as 27 g individual sachet, administered orally as a single serve.
OTHERControl
Energy equivalent beverage powder without micronutrient fortification, packed as 27 g individual sachets, administered orally as a single serve
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* Demonstrates understanding of the study and willingness to participate as evidenced by participants' parents and/or legal guardian's voluntary written informed consent as well as written assent by the participant and has received a signed and dated copy of the informed consent form as well as the assent form * Participant belonging to middle socio-economic background as per modified Kuppuswamy scale * Good general and mental health with, in the opinion of the investigator or medically qualified designee * Child residing in the peri-urban areas of Bangalore city * Child with Z-scores of: a. height for age of 0 to ≥-3; b. BMI for age of 0 to ≥-3.
Exclusion criteria
* Children in Care (CiC) * Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds), any of their stated ingredients or any known food allergies like peanut allergy, gluten allergy or lactose intolerance * Participants with severe anaemia (Haemoglobin \< 8g %) as determined by laboratory results * Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the participant unlikely to fully complete the study or any condition that presents undue risk from the study product or procedures in the opinion of the investigator * Recent history (3 months) of serious infections, injuries and/ or surgeries * Children consuming iron, calcium and/or other nutritional supplements and/ or health food drinks on a regular basis (more than 3 times a week) in last 6 months prior to screening visit * Use of any prescription medications within 15 days prior to screening and throughout the entire duration of the study * Recent history (within the last 1 year) of alcohol or other substance abuse.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fractional Iron Absorption | Day 15 | Iron uptake was measured using stable isotopes of 57Fe and 58Fe to label the test and control products. Fractional iron absorption levels of 57Fe and 58Fe were calculated, to give a direct measure of the iron uptake from each of the study treatments. |
Countries
India
Participant flow
Recruitment details
Participants were recruited from two centers in India.
Pre-assignment details
A total of 37 participants were screened, 25 were randomized and 24 completed the study. One participant withdrew from the study due to an adverse event (AE).
Participants by arm
| Arm | Count |
|---|---|
| Overall Micronutrient fortified nutritional beverage powder (test) and energy, iron and calcium equivalent beverage powder without micronutrient fortification (control), packed as 27 g individual sachets, administered as a single serve in a total volume of 100 mL lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder. Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous Years | 8.60 Years STANDARD_DEVIATION 1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 25 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 25 | 0 / 24 |
| serious Total, serious adverse events | 0 / 25 | 0 / 24 |
Outcome results
Primary
Fractional Iron Absorption
Iron uptake was measured using stable isotopes of 57Fe and 58Fe to label the test and control products. Fractional iron absorption levels of 57Fe and 58Fe were calculated, to give a direct measure of the iron uptake from each of the study treatments.
Time frame: Day 15
Population: Per protocol (PP) population, defined as all participants who received at least one study treatment administration and who did not have any protocol violations deemed to affect evaluation of the iron absorption. This analysis was conducted on PP population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Test | Fractional Iron Absorption | 2.08 % Iron Absorbed | Standard Deviation 1.263 |
| Control | Fractional Iron Absorption | 1.25 % Iron Absorbed | Standard Deviation 0.922 |
p-value: 0.094495% CI: [0.9, 3.34]ANOVA