Investigation of Iron Uptake From Micronutrient Fortified Powder Versus From Tailored Control in Milk

NCT02254460 | Completed Results

• 2 other identifiers: 202738RH01592
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Growth and Development

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 15

Study Arms (2)

Test

EXPERIMENTAL

Experimental product: Micronutrient fortified beverage powder, packed as 27 g individual sachet, administered orally as a single serve.

Dietary Supplement: Test

Control

PLACEBO COMPARATOR

Energy equivalent beverage powder without micronutrient fortification, packed as 27 g individual sachets, administered orally as a single serve

Other: Control

Interventions

Test DIETARY_SUPPLEMENT

Experimental product: Micronutrient fortified beverage powder, packed as 27 g individual sachet, administered orally as a single serve.

Test

Control OTHER

Energy equivalent beverage powder without micronutrient fortification, packed as 27 g individual sachets, administered orally as a single serve

Control

Eligibility Criteria

• Age: 7 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Bangalore, 560034, India

Location

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 1, 2014
• Study Start: February 6, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 8, 2013
• Last Updated: July 11, 2017
• Results First Posted: March 16, 2017

Record last verified: 2017-06

Locations

IN (1)