Milk Supplementation and Bone Health in Children
Effects of Yili Child Formula Milk on Bone Health in 4-6 Year Children: a 12-month Randomized Controlled Trial
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.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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-
Gangshu
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Lanzhou、Gangshu、中国、730000
- LanZhou University
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Formula Milk
Formula milk designed for young children aged over 3 years; Dosage: 195 ml/time; Frequence: 2 times /day; Duration: 12 months |
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 |
|
アクティブコンパレータ：Regular milk
Regular milk (pure milk); Dosage: 195 ml/time; Frequence: 2 times /day; Duration: 12 months |
Brand name: Yili； Type: regular milk (pure milk); Dosage: 195ml*2/d; Intervention duration: 12 months |
|
他の：Control foods
Grain foods: e.g., bread; Dosage: 20-40 g/time; Frequence: 2 times /day; Duration: 12 months |
Brand: N/A; Food type: grain foods (e.g., bread); Dosage: 20-40g * 2/d grain foods Intervention duration: 12 months |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline bone mineral density (BMD) at 12 months
時間枠：0 and 12 months
|
BMD (g/cm2) determined by a dual energy x-ray absorptiometry (DXA) at the left forearm and heel
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0 and 12 months
|
|
Change from baseline bone mineral density (BMD) at 6 months
時間枠：0 and 6 months
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BMD (g/cm2) determined by DXA at the left forearm and heel
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0 and 6 months
|
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Change from baseline bone mineral contents (BMC) at 12 months
時間枠：0 and 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
時間枠：0 and 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
時間枠：0 and 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
時間枠：0 and 6 months
|
Bone turnover marker 1: Bone-specific alkaline phosphatase
|
0 and 6 months
|
|
Change from baseline of osteocalcin at 12 months
時間枠：0 and 12 months
|
Bone turnover marker 2: osteocalcin
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0 and 12 months
|
|
Change from baseline of osteocalcin at 6 months
時間枠：0 and 6 months
|
Bone turnover marker 2: osteocalcin
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0 and 6 months
|
|
Change from baseline of C-terminal telopeptide of type I collagen at 12 months
時間枠：0 and 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
時間枠：0 and 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
時間枠：0 and 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
時間枠：0 and 6 months
|
Bone turnover marker 4: tartrate resistant acid phosphatase
|
0 and 6 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change from baseline body weight at 12 months
時間枠：0 and 12 months
|
Anthropometric indices: body weight
|
0 and 12 months
|
|
Change from baseline body height at 12 months
時間枠：0 and 12 months
|
Anthropometric indices: body height
|
0 and 12 months
|
|
Change from baseline biomarker of body growth at 12 months
時間枠：0 and 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
時間枠：0 and 12 months
|
Immune status: Blood Ig M
|
0 and 12 months
|
|
Change from baseline immune globulin G (Ig G）at 12 months
時間枠：0 and 12 months
|
Immune status: Blood Ig G
|
0 and 12 months
|
|
Change from baseline immune globulin G (Ig A）at 12 months
時間枠：0 and 12 months
|
Immune status: Blood Ig A
|
0 and 12 months
|
|
Change from baseline whit blood cell at 12 months
時間枠：0 and 12 months
|
Immune status: whit blood cell
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0 and 12 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Concentrations of blood total 25-hydroxide-vitamin D (25-OH-VD)
時間枠：0, 6 and 12 months
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Serum 25-OH-VD
|
0, 6 and 12 months
|
|
Concentrations of blood parathyroid Hormone (PTH)
時間枠：0, 6 and 12 months
|
Serum PTH
|
0, 6 and 12 months
|
|
Nutritional status 1: Body weight
時間枠：0, 4, 8 and 12 months
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Body weight (in kg)
|
0, 4, 8 and 12 months
|
|
Nutritional status 2: waist circumference
時間枠：0, 4, 8 and 12 months
|
Waist circumference (in cm)
|
0, 4, 8 and 12 months
|
|
Nutritional status 3: middle-arm circumference
時間枠：0, 4, 8 and 12 months
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Middle-arm circumference (in cm)
|
0, 4, 8 and 12 months
|
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Nutritional status 4: skinfold thickness
時間枠：0, 4, 8 and 12 months
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Skinfold thickness (in mm)
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0, 4, 8 and 12 months
|
|
Total consumption of milk and dairy food
時間枠：0, 4, 8 and 12 months
|
Total consumption of milk and dairy food (in ml/d)
|
0, 4, 8 and 12 months
|
|
Consumption of dietary energy
時間枠：0, 4, 8 and 12 months
|
Consumption of dietary energy (in kcal/d)
|
0, 4, 8 and 12 months
|
|
Consumption of dietary protein
時間枠：0, 4, 8 and 12 months
|
Consumption of dietary protein (in g/d)
|
0, 4, 8 and 12 months
|
|
Consumption of dietary calcium
時間枠：0, 4, 8 and 12 months
|
Consumption of dietary calcium (in mg/d)
|
0, 4, 8 and 12 months
|
|
Number of participants with treatment-related adverse events
時間枠：0, 4, 8 and 12 months
|
Adverse events : assessed by using questionnaires of medical conditions, medications related to milk intake
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0, 4, 8 and 12 months
|
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Child behaviors
時間枠：0 and 12 months
|
Child behaviours: assessed by using a Child behavior Questionnaire-- parent version.
The minimum and maximum values: 26-78; higher scores mean worse outcome.
|
0 and 12 months
|
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Physical activity
時間枠：0, 4, 8 and 12 months
|
Physical activity (in MET, h/week): assessed by a Child Physical Activity Questionnaire
|
0, 4, 8 and 12 months
|
|
Concentrations of serum calcium
時間枠：0, 6 and 12 months
|
Serum calcium (mmol/L)
|
0, 6 and 12 months
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Yuming Chen, Ph.D.、Sun Yat-sen University
- スタディチェア：Zhifu Zhao, M. Phil、Inner Mongolia Dairy Technology Research Institute Co., Ltd.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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