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| ID | Type | Description | Link |
|---|---|---|---|
| RH01817 | Other Identifier | GSK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional supplement with micronutrient | Active Comparator | Nutritional supplement powder with micronutrients packed as 27 g individual sachet, administered orally as a single serve twice daily |
|
| Nutritional supplement without micronutrient | Sham Comparator | Nutritional supplement powder without micronutrients packed as 27 g individual sachet, administered orally as a single serve twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional supplement with micronutrient | Dietary Supplement | Nutritional supplement powder with micronutrients packed as 27 g individual sachet, administered orally as a single serve |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Bangalore | 560043 | India |
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| Label | URL |
|---|---|
| Results for Study 201133 can be found on the GSK Clinical Study Register | View source |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D018977 | Micronutrients |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Nutritional supplement without micronutrient | Dietary Supplement | Nutritional supplement powder without micronutrients packed as 27 g individual sachet, administered orally as a single serve |
|
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 |
| D045505 |
| Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000078622 | Nutrients |