NCT05074836

Milk Supplementation and Bone Health in Children

Effects of Yili Child Formula Milk on Bone Health in 4-6 Year Children: a 12-month Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 254 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 48 Months – 83 Months
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Bone Density Increased
• Body Height

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Formula milk	Brand name: Yili (QQ star formula milk); Type: SCI-PRO NUTRI 5+6TM formula milk designed for young children aged over 3 years; Dosage: 195ml\*2/d; Intervention duration: 12 months
DIETARY_SUPPLEMENT	Regular milk	Brand name: Yili； Type: regular milk (pure milk); Dosage: 195ml\*2/d; Intervention duration: 12 months
OTHER	Control foods	Brand: N/A; Food type: grain foods (e.g., bread); Dosage: 20-40g \* 2/d grain foods Intervention duration: 12 months

Timeline

• Start date: 2021-09-03
• Primary completion: 2022-10-30
• Completion: 2022-12-30
• First posted: 2021-10-12
• Last updated: 2021-10-12

Locations

1 site across 1 country: China