Milk Supplementation and Bone Health in Children

Sun Yat-sen University254 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

254

Conditions

Bone Density Increased Body Height

Interventions

Formula milkDIETARY_SUPPLEMENT

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 milkDIETARY_SUPPLEMENT

Brand name: Yili； Type: regular milk (pure milk); Dosage: 195ml\*2/d; Intervention duration: 12 months

Control foodsOTHER

Brand: N/A; Food type: grain foods (e.g., bread); Dosage: 20-40g \* 2/d grain foods Intervention duration: 12 months

Eligibility

Sex: ALLMin age: 48 MonthsMax age: 83 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Lanzhou University

Lanzhou, Gangshu, China

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: 0 and 6 months

Change from baseline of bone-specific alkaline phosphatase at 12 months

Bone turnover marker 1: Bone-specific alkaline phosphatase

Time frame: 0 and 12 months

Change from baseline of bone-specific alkaline phosphatase at 6 months

Bone turnover marker 1: Bone-specific alkaline phosphatase

Time frame: 0 and 6 months

Change from baseline of osteocalcin at 12 months

Bone turnover marker 2: osteocalcin

Time frame: 0 and 12 months

Change from baseline of osteocalcin at 6 months

Bone turnover marker 2: osteocalcin

Time frame: 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

Time frame: 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

Time frame: 0 and 6 months

Change from baseline of tartrate resistant acid phosphatase at 12 months

Bone turnover marker 4: tartrate resistant acid phosphatase

Time frame: 0 and 12 months

Change from baseline of tartrate resistant acid phosphatase at 6 months

Bone turnover marker 4: tartrate resistant acid phosphatase

Time frame: 0 and 6 months

Secondary Outcomes

Change from baseline body weight at 12 months

Anthropometric indices: body weight

Time frame: 0 and 12 months

Change from baseline body height at 12 months

Anthropometric indices: body height

Time frame: 0 and 12 months

Change from baseline biomarker of body growth at 12 months

Biomarker of body growth: insulin-like growth factor 1

Time frame: 0 and 12 months

Change from baseline immune globulin M (Ig M）at 12 months

Immune status: Blood Ig M

Time frame: 0 and 12 months

Change from baseline immune globulin G (Ig G）at 12 months

Immune status: Blood Ig G

Time frame: 0 and 12 months

Change from baseline immune globulin G (Ig A）at 12 months

Immune status: Blood Ig A

Time frame: 0 and 12 months

Change from baseline whit blood cell at 12 months

Immune status: whit blood cell

Time frame: 0 and 12 months

Data from ClinicalTrials.gov

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