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
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.
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.
Exclusion Criteria:
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
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
Nutritional supplement powder with micronutrients packed as 27 g individual sachet, administered orally as a single serve
Nutritional supplement powder without micronutrients packed as 27 g individual sachet, administered orally as a single serve
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
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
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
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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GlaxoSmithKline