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

Study Overview
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Brief Summary
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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.

Official 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

Conditions
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Nutritional Status

Intervention / Treatment
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* Dietary Supplement: Nutritional supplement with micronutrient
* Dietary Supplement: Nutritional supplement without micronutrient


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutritional supplement with micronutrient<br>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<br>* Nutritional supplement powder with micronutrients packed as 27 g individual sachet, administered orally as a single serve<br>|
| Sham Comparator: Nutritional supplement without micronutrient<br>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<br>* Nutritional supplement powder without micronutrients packed as 27 g individual sachet, administered orally as a single serve<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |