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

NCT02201225 | Completed Phase 1

• 2 other identifiers: 201133RH01817
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nutritional Status

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from Baseline to Week 12 in Z-score based on the standing height

  Baseline-Week 12

• Change from Baseline to Week 8 in bone growth, as measured by sitting knee length digital caliper

  Baseline-Week 8

Study Arms (2)

Nutritional supplement with micronutrient

ACTIVE COMPARATOR

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 without micronutrient

SHAM COMPARATOR

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

Interventions

Nutritional supplement with micronutrient DIETARY_SUPPLEMENT

Nutritional supplement powder with micronutrients packed as 27 g individual sachet, administered orally as a single serve

Nutritional supplement with micronutrient

Nutritional supplement without micronutrient DIETARY_SUPPLEMENT

Nutritional supplement powder without micronutrients packed as 27 g individual sachet, administered orally as a single serve

Nutritional supplement without micronutrient

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Bangalore, 560043, India

Location

Related Links

• Results for Study 201133 can be found on the GSK Clinical Study Register

MeSH Terms

Interventions

Dietary Supplements; Micronutrients

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 28, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 13, 2015
• Last Updated: January 12, 2018

Record last verified: 2018-01

Locations

IN (1)