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

NCT ID: NCT02254460

Last Updated: 2017-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-06
• Study Completion Date: 2013-03-08

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Test

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

Group Type: EXPERIMENTAL

Test

Intervention Type: DIETARY_SUPPLEMENT

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

Control

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

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

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

Interventions

Test

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

Intervention Type: DIETARY_SUPPLEMENT

Control

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Bangalore, , India

Countries

India

Other Identifiers

RH01592

Identifier Type: OTHER

Identifier Source: secondary_id

202738

Identifier Type: -

Identifier Source: org_study_id