Milk Supplementation and Bone Health in Children

Study Overview
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Brief Summary
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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.

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

Conditions
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Bone Density Increased, Body Height

Intervention / Treatment
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* Dietary Supplement: Formula milk
* Dietary Supplement: Regular milk
* Other: Control foods


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged between 4-6 years; female and male Can be enrolled into kindergarten/school as a normal child. Be willing to drinking milk daily. Exclusion Criteria: Milk allergy or intolerance, did not to be used to drinking milk; 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.

Ages Eligible for Study
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Minimum Age: 48 Months
Maximum Age: 83 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formula Milk<br>Formula milk designed for young children aged over 3 years; Dosage: 195 ml/time; Frequence: 2 times /day; Duration: 12 months | Dietary Supplement: Formula milk<br>* 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<br>|
| Active Comparator: Regular milk<br>Regular milk (pure milk); Dosage: 195 ml/time; Frequence: 2 times /day; Duration: 12 months | Dietary Supplement: Regular milk<br>* Brand name: Yili； Type: regular milk (pure milk); Dosage: 195ml*2/d; Intervention duration: 12 months<br>|
| Other: Control foods<br>Grain foods: e.g., bread; Dosage: 20-40 g/time; Frequence: 2 times /day; Duration: 12 months | Other: Control foods<br>* Brand: N/A; Food type: grain foods (e.g., bread); Dosage: 20-40g * 2/d grain foods Intervention duration: 12 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline bone mineral density (BMD) at 12 months | BMD (g/cm2) determined by a dual energy x-ray absorptiometry (DXA) at the left forearm and heel | 0 and 12 months | 
| Change from baseline bone mineral density (BMD) at 6 months | BMD (g/cm2) determined by DXA at the left forearm and heel | 0 and 6 months | 
| Change from baseline bone mineral contents (BMC) at 12 months | BMC (g) determined by DXA at the left forearm and heel. | 0 and 12 months | 
| Change from baseline bone mineral contents (BMC) at 6 months | BMC (g) determined by DXA at the left forearm and heel. | 0 and 6 months | 
| Change from baseline of bone-specific alkaline phosphatase at 12 months | Bone turnover marker 1: Bone-specific alkaline phosphatase | 0 and 12 months | 
| Change from baseline of bone-specific alkaline phosphatase at 6 months | Bone turnover marker 1: Bone-specific alkaline phosphatase | 0 and 6 months | 
| Change from baseline of osteocalcin at 12 months | Bone turnover marker 2: osteocalcin | 0 and 12 months | 
| Change from baseline of osteocalcin at 6 months | Bone turnover marker 2: osteocalcin | 0 and 6 months | 
| Change from baseline of C-terminal telopeptide of type I collagen at 12 months | Bone turnover marker 3: C-terminal telopeptide of type I collagen | 0 and 12 months | 
| Change from baseline of C-terminal telopeptide of type I collagen at 6 months | Bone turnover marker 3: C-terminal telopeptide of type I collagen | 0 and 6 months | 
| Change from baseline of tartrate resistant acid phosphatase at 12 months | Bone turnover marker 4: tartrate resistant acid phosphatase | 0 and 12 months | 
| Change from baseline of tartrate resistant acid phosphatase at 6 months | Bone turnover marker 4: tartrate resistant acid phosphatase | 0 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline body weight at 12 months | Anthropometric indices: body weight | 0 and 12 months | 
| Change from baseline body height at 12 months | Anthropometric indices: body height | 0 and 12 months | 
| Change from baseline biomarker of body growth at 12 months | Biomarker of body growth: insulin-like growth factor 1 | 0 and 12 months | 
| Change from baseline immune globulin M (Ig M）at 12 months | Immune status: Blood Ig M | 0 and 12 months | 
| Change from baseline immune globulin G (Ig G）at 12 months | Immune status: Blood Ig G | 0 and 12 months | 
| Change from baseline immune globulin G (Ig A）at 12 months | Immune status: Blood Ig A | 0 and 12 months | 
| Change from baseline whit blood cell at 12 months | Immune status: whit blood cell | 0 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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milk, bone health, body growth, young children