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

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ClinicalTrials.gov Identifier: NCT02254460
Recruitment Status : Completed
First Posted : October 1, 2014
Results First Posted : March 16, 2017
Last Update Posted : July 11, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Growth and Development Dietary Supplement: Test Other: Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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.
Study Start Date : February 6, 2013
Actual Primary Completion Date : March 1, 2013
Actual Study Completion Date : March 8, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

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

Placebo Comparator: Control
Energy equivalent beverage powder without micronutrient fortification, packed as 27 g individual sachets, 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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   7 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02254460


Locations
India
GSK Investigational Site
Bangalore, India, 560034
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT02254460     History of Changes
Other Study ID Numbers: 202738
RH01592 ( Other Identifier: GSK )
First Posted: October 1, 2014    Key Record Dates
Results First Posted: March 16, 2017
Last Update Posted: July 11, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs