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

Growth and Development Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02254460
• Other study ID #: 202738
• Secondary ID: RH01592
• Status: Completed
• Phase: N/A
• First received: September 29, 2014
• Last updated: January 29, 2015
• Start date: February 2013
• Est. completion date: March 2013

Study information

• Verified date: January 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 10 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Growth and Development

Intervention

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

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional iron absorption	Iron absorption from each of the treatment regimens will be measured 14 days after the first treatment is administered (i.e. on study day 15). This will be expressed as percentage(%) iron absorbed. Blood samples will be collected from each participant on the 15th day and all isotopic analysis will be carried on a negative thermal ionization mass spectrometer (Triton) equipped with a multicollector system for simultaneous ion beam detection. The % iron absorbed will be log transformed prior to analysis, and analysed using an analysis of covariance (ANCOVA). The ANCOVA will include factors for sequence, participant within sequence (random effect), treatment group, study period and gender, with baseline levels of 57 Fe and 58 Fe isotopes as a covariate.	15 days	No