Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
254 participants
INTERVENTIONAL
2021-09-03
2022-12-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Formula Milk
Formula milk designed for young children aged over 3 years;
Dosage: 195 ml/time;
Frequence: 2 times /day;
Duration: 12 months
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
Regular milk
Regular milk (pure milk);
Dosage: 195 ml/time;
Frequence: 2 times /day;
Duration: 12 months
Regular milk
Brand name: Yili；
Type: regular milk (pure milk);
Dosage: 195ml\*2/d;
Intervention duration: 12 months
Control foods
Grain foods: e.g., bread;
Dosage: 20-40 g/time;
Frequence: 2 times /day;
Duration: 12 months
Control foods
Brand: N/A;
Food type: grain foods (e.g., bread);
Dosage: 20-40g \* 2/d grain foods
Intervention duration: 12 months
Interventions
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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
Regular milk
Brand name: Yili；
Type: regular milk (pure milk);
Dosage: 195ml\*2/d;
Intervention duration: 12 months
Control foods
Brand: N/A;
Food type: grain foods (e.g., bread);
Dosage: 20-40g \* 2/d grain foods
Intervention duration: 12 months
Eligibility Criteria
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Inclusion Criteria
* female and male
* Can be enrolled into kindergarten/school as a normal child.
* Be willing to drinking milk daily.
Exclusion Criteria
* Had the following diseases/conditions confirmed by a hospital: serious diseases of heart, liver, kidney, brain, hematopoietic system, immunity, thyroid or cancer that need to be hospitalization for more than 1 week or take medication(s) for more than 1 month with the past two years.
* having infectious diseases, e.g., tuberculosis, hepatitis, etc.
* Taking vitamin D, calcium tables or nutrient package;
* Consumed more than 3 times (\>600ml) milk each week in the previous month.
* Be not willing to provide informed consent, or have other conditions that were considered to be unsuitable for the study by the investigators.
* Increases of body health were out of the range between 5-8 cm in the last year.
48 Months
83 Months
ALL
Yes
Sponsors
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LanZhou University
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Yu-ming Chen
Professor
Principal Investigators
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Yuming Chen, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Sun Yat-sen University
Zhifu Zhao, M. Phil
Role: STUDY_CHAIR
Inner Mongolia Dairy Technology Research Institute Co., Ltd.
Locations
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Lanzhou University
Lanzhou, Gangshu, China
Countries
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References
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Zhao ZF, Li BY, He Q, Hao JY, Zhang KS, Zhang B, Hu W, Feng HT, Szeto IM, Chen YM, Zhang GX, Tang XY. Impact of dairy supplementation on bone acquisition in children's limbs: a 12-month cluster-randomized controlled trial and meta-analysis. Arch Osteoporos. 2024 Jul 24;19(1):65. doi: 10.1007/s11657-024-01422-2.
Other Identifiers
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SYSU-51000-20210723-0001
Identifier Type: -
Identifier Source: org_study_id