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

Nutritional Status Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201225
• Other study ID #: 201133
• Secondary ID: RH01817
• Status: Completed
• Phase: Phase 1
• First received: July 24, 2014
• Last updated: January 10, 2018
• Start date: October 1, 2014
• Est. completion date: March 13, 2015

Study information

• Verified date: January 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: March 13, 2015
• Est. primary completion date: March 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nutritional Status

Intervention

Dietary Supplement:
• Nutritional supplement with micronutrient
Nutritional supplement powder with micronutrients packed as 27 g individual sachet, administered orally as a single serve
• Nutritional supplement without micronutrient
Nutritional supplement powder without micronutrients packed as 27 g individual sachet, administered orally as a single serve

Locations

Country	Name	City	State
India	GSK Investigational Site	Bangalore

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

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