Bone Density Increased Clinical Trial
Official title:
Effects of Yili Child Formula Milk on Bone Health in 4-6 Year Children: a 12-month Randomized Controlled Trial
Objectives: to examine the effects of a Yili child formula milk and regular milk on bone health and growth in young children. Study design: cluster randomized controlled trial. Setting: kindergartens in Hui-ning County of Gansu Province, China (north west). Participants: >=246 apparent healthy children aged 4-6 years old. Interventions: (I) Yili child formula milk (QQ star formula, SCI-PRO NUTR5+6TM), 195 ml *2 /day; (II) Yili regular milk (pure milk), 195ml*2 /day; (III) Controls: about 50g/d grain foods (containing 20-30 g carbohydrates), e.g. bread. Interventional Duration: 12 months. Outcome measures: determined at 0, 6 and 12 months post treatments. Primary outcomes: bone density and bone mineral contents at the forearm and heel, bone biomarkers. Secondary outcomes: (1) anthropometric indices: weight, height, waist circumference, etc.; (2) immune status. Other measures: dietary intakes, physical activities, general information, medical information, adverse of side effects. Data Analyses: The one-year changes and percent changes in the primary and secondary outcomes will be compared among the 3 groups.
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Not yet recruiting |
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