Effects of Yili Child Formula Milk on Bone Health in 4-6 Year Children: a 12-month Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Change from baseline bone mineral density (BMD) at 6 months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The two milk products have the same-looking package and similar taste.
入排标准
- 年龄范围
- 48 Months 至 83 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 4-6 years;
- •female and male
- •Can be enrolled into kindergarten/school as a normal child.
- •Be willing to drinking milk daily.
排除标准
- •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.
研究组 & 干预措施
Formula Milk
Formula milk designed for young children aged over 3 years;
Dosage: 195 ml/time;
Frequence: 2 times /day;
Duration: 12 months
干预措施: Formula milk (Dietary Supplement)
Regular milk
Regular milk (pure milk);
Dosage: 195 ml/time;
Frequence: 2 times /day;
Duration: 12 months
干预措施: Regular milk (Dietary Supplement)
Control foods
Grain foods: e.g., bread;
Dosage: 20-40 g/time;
Frequence: 2 times /day;
Duration: 12 months
干预措施: Control foods (Other)
结局指标
主要结局
Change from baseline bone mineral density (BMD) at 6 months
时间窗: 0 and 6 months
BMD (g/cm2) determined by DXA at the left forearm and heel
Change from baseline bone mineral contents (BMC) at 12 months
时间窗: 0 and 12 months
BMC (g) determined by DXA at the left forearm and heel.
Change from baseline bone mineral contents (BMC) at 6 months
时间窗: 0 and 6 months
BMC (g) determined by DXA at the left forearm and heel.
Change from baseline of osteocalcin at 12 months
时间窗: 0 and 12 months
Bone turnover marker 2: osteocalcin
Change from baseline of osteocalcin at 6 months
时间窗: 0 and 6 months
Bone turnover marker 2: osteocalcin
Change from baseline of tartrate resistant acid phosphatase at 12 months
时间窗: 0 and 12 months
Bone turnover marker 4: tartrate resistant acid phosphatase
Change from baseline bone mineral density (BMD) at 12 months
时间窗: 0 and 12 months
BMD (g/cm2) determined by a dual energy x-ray absorptiometry (DXA) at the left forearm and heel
Change from baseline of C-terminal telopeptide of type I collagen at 6 months
时间窗: 0 and 6 months
Bone turnover marker 3: C-terminal telopeptide of type I collagen
Change from baseline of tartrate resistant acid phosphatase at 6 months
时间窗: 0 and 6 months
Bone turnover marker 4: tartrate resistant acid phosphatase
Change from baseline of bone-specific alkaline phosphatase at 12 months
时间窗: 0 and 12 months
Bone turnover marker 1: Bone-specific alkaline phosphatase
Change from baseline of C-terminal telopeptide of type I collagen at 12 months
时间窗: 0 and 12 months
Bone turnover marker 3: C-terminal telopeptide of type I collagen
Change from baseline of bone-specific alkaline phosphatase at 6 months
时间窗: 0 and 6 months
Bone turnover marker 1: Bone-specific alkaline phosphatase
次要结局
- Change from baseline whit blood cell at 12 months(0 and 12 months)
- Change from baseline immune globulin G (Ig G）at 12 months(0 and 12 months)
- Change from baseline immune globulin G (Ig A）at 12 months(0 and 12 months)
- Change from baseline biomarker of body growth at 12 months(0 and 12 months)
- Change from baseline immune globulin M (Ig M）at 12 months(0 and 12 months)
- Change from baseline body weight at 12 months(0 and 12 months)
- Change from baseline body height at 12 months(0 and 12 months)
研究者
Yu-ming Chen
Professor
Sun Yat-sen University