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CompletedNCT02201225Updated Jan 12, 2018

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

A Phase 1 interventional study of Nutritional supplement with micronutrient and Nutritional supplement without micronutrient in Nutritional Status, sponsored by GlaxoSmithKline. Completed at 1 site in India. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-01-12.

Sponsored by GlaxoSmithKline · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
109
Allocation
Randomized
Ages
6 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nutritional Status
03

In context

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
109 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Dietary supplementNutritional supplement with micronutrient

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

  • Dietary supplementNutritional supplement without micronutrient

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

06

What researchers measure

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.

    Time frame: Baseline to Week 12

Secondary outcomes

  1. 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

    Time frame: Baseline-Week 12

  2. 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

    Time frame: Baseline-Week 8

07

Study locations

1 site
  • GSK Investigational Site
    Bangalore, 560043, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02201225
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 28, 2014
Start date
Oct 1, 2014
Primary completion
Mar 1, 2015
Completion
Mar 13, 2015
Last update
Jan 12, 2018

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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