Status:
COMPLETED
A Methodology Study to Evaluate a Sitting Knee Measuring Device in Assessing Growth in Indian Children.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Nutritional Status
Eligibility:
All Genders
6-12 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 13 2015
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT02201225
Start Date
October 1 2014
End Date
March 13 2015
Last Update
January 12 2018
Active Locations (1)
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1
GSK Investigational Site
Bangalore, India, 560043