Last updated: 11/03/2018 21:17:24

A methodology study to evaluate a sitting knee measuring device in assessing growth in Indian children.

GSK study ID
201133
See study documents
Clinicaltrials.gov ID
NCT02201225
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

Change from Baseline to Week 12 in bone growth, as measured by sitting knee length caliper.

Timeframe: Baseline to Week 12

Secondary outcomes:

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

Timeframe: Baseline-Week 12

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

Timeframe: Baseline-Week 8

Interventions:
Dietary supplement: Nutritional supplement with micronutrient
Dietary supplement: Nutritional supplement without micronutrient
Enrollment:
109
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Nutritional status
Product
GSK3129091
Collaborators
Not applicable
Study date(s)
October 2014 to March 2015
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
6 - 12 years
Accepts healthy volunteers
Yes
  • 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 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
Inclusion and exclusion criteria
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.

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Bangalore, India, 560043
6.2 miles (9.9 km) away from your location
Status
Study Complete
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Study documents

Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2015-13-03

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Participate in clinical trial
Additional information
Results for Study 201133 can be found on the GSK Clinical Study Register
Click here
Access to clinical trial data by researchers
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