A Double Blind, Randomized, Two-way Cross-over Study to Investigate the Uptake of Iron From Micronutrient Fortified Powder vs. From Tailored Control in Milk.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Fractional Iron Absorption
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 7 Years to 10 Years (Child)
- Sex
- All
- Accepts 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.
Arms & Interventions
Test
Experimental product: Micronutrient fortified beverage powder, packed as 27 g individual sachet, administered orally as a single serve.
Intervention: Test (Dietary Supplement)
Control
Energy equivalent beverage powder without micronutrient fortification, packed as 27 g individual sachets, administered orally as a single serve
Intervention: Control (Other)
Outcomes
Primary Outcomes
Fractional Iron Absorption
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported