A Methodology Study to Evaluate a Sitting Knee Measuring Device in Assessing Growth in Indian Children.

A Methodology Study to Evaluate a Sitting Knee Measuring Device in Assessing Growth in Indian Children Aged 6 to 12 Years Receiving Nutritional Supplement With or Without Micronutrient Fortification

This methodology study will evaluate the sensitivity in using sitting knee digital caliper to measure changes in sitting knee length from over a 12-week study period amidst children in the age of 6 to 12 years in a community-based study in children ages 6 to 12 years who are receiving nutritional supplementation with micronutrients or without micronutrients.

Study Overview

• Status: Completed
• Conditions: Nutritional Status
• Intervention / Treatment: Dietary supplement: Nutritional supplement with micronutrient; Dietary supplement: Nutritional supplement without micronutrient

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Bangalore, India, 560043
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children (participants), both boys and girls, aged 6 to 12 years.
• Participant height to be within the 25th to the 75th percentile of the standard height average in Indian children population
• Participant will agree not to take any other nutritional supplements products during the study except the trial supplement

Exclusion Criteria:

• Participant has any of the following medical conditions: Genetic disorders, chronic disease, metabolic disorders, endocrine disorders, immobilisation, and miscellaneous
• Participant who in the past 6 months has used dietary or nutritional supplements with micronutrient fortification, or any form of dietary or herbal supplement intended to increase micronutrient intake, at a frequency of greater than 3-4times per month.
• Participant receiving any supplements (such as calcium, iron and/or multivitamin at the time of screening).
• Children (Participant) in Care are not allowed to participate in the study.
• Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
• Health conditions that would affect food metabolism including the following food allergies, kidney disease, liver disease, and/or gastrointestinal diseases (e.g. irritable bowel syndrome, celiac disease, peptic ulcers).
• Use of concomitant medications that, in the opinion of the Principal Investigator (PI), might interfere with the outcome of the study or increases the risk of the participant, including corticosteroids (systemic or inhaled) and any medication for any behaviour-related disorders and/or stimulants.
• Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder, including history of alcohol or substance abuse, 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 PI/medical examiner.
• Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
• Personnel: Currently, the participant's parents/legal guardian is an employee of the Sponsor or the study or members of their immediate family.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nutritional supplement with micronutrient; Nutritional supplement powder with micronutrients packed as 27 g individual sachet, administered orally as a single serve twice daily	Dietary supplement: Nutritional supplement with micronutrient; Nutritional supplement powder with micronutrients packed as 27 g individual sachet, administered orally as a single serve
Sham Comparator: Nutritional supplement without micronutrient; Nutritional supplement powder without micronutrients packed as 27 g individual sachet, administered orally as a single serve twice daily	Dietary supplement: Nutritional supplement without micronutrient; Nutritional supplement powder without micronutrients packed as 27 g individual sachet, administered orally as a single serve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to Week 12 in bone growth, as measured by sitting knee length caliper.	To evaluate the sensitivity of a sitting knee digital caliper to measure changes in sitting knee length from Baseline to Week 12 in a community-based study in the presence of nutritional supplementation with or without micronutrients.	Baseline to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline to Week 12 in Z-score based on the standing height	Comparison of standing height and sitting knee height to asses growth	Baseline-Week 12
Change from Baseline to Week 8 in bone growth, as measured by sitting knee length digital caliper	To assess the relationship between changes from Baseline to Week 8 in sitting knee length and standing height in the presence of nutritional supplementation with or without micronutrients	Baseline-Week 8

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 13, 2015

Study Registration Dates

• First Submitted: July 24, 2014
• First Submitted That Met QC Criteria: July 24, 2014
• First Posted (Estimate): July 28, 2014

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Trace Elements
• Other Study ID Numbers: 201133; RH01817 (Other Identifier: GSK)