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Milk Supplementation and Bone Health in Children

NCT05074836 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 254

Last updated 2021-10-12

No results posted yet for this study

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

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

Sponsors & Collaborators

  • LanZhou University

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yuming Chen, Ph.D. · Sun Yat-sen University

  • Zhifu Zhao, M. Phil · Inner Mongolia Dairy Technology Research Institute Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
48 Months
Max Age
83 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-03
Primary Completion
2022-10-30
Completion
2022-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05074836 on ClinicalTrials.gov