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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02201225 |
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Date of registration:
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24/07/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Methodology Study to Evaluate a Sitting Knee Measuring Device in Assessing Growth in Indian Children.
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Scientific title:
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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 |
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Date of first enrolment:
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October 1, 2014 |
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Target sample size:
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109 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02201225 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1
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Countries of recruitment
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India
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Contacts
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Name:
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GSK Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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GlaxoSmithKline |
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Key inclusion & exclusion criteria
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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.
Age minimum:
6 Years
Age maximum:
12 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Nutritional Status
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Intervention(s)
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Dietary Supplement: Nutritional supplement with micronutrient
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Dietary Supplement: Nutritional supplement without micronutrient
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Primary Outcome(s)
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Change from Baseline to Week 12 in bone growth, as measured by sitting knee length caliper.
[Time Frame: Baseline to Week 12]
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Secondary Outcome(s)
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Change from Baseline to Week 8 in bone growth, as measured by sitting knee length digital caliper
[Time Frame: Baseline-Week 8]
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Change from Baseline to Week 12 in Z-score based on the standing height
[Time Frame: Baseline-Week 12]
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Secondary ID(s)
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RH01817
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201133
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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