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Completed

NCT Number: NCT02201225

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

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.

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Key information

Conditions

Nutritional Status

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Bangalore, 560043, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 without micronutrient

Dietary Supplement

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

Primary outcomes

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

    Time frame: Baseline to Week 12

    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.

Secondary outcomes

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

    Time frame: Baseline-Week 12

    Comparison of standing height and sitting knee height to asses growth

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

    Time frame: Baseline-Week 8

    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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 28, 2014
Registry last updated
Jan 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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