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.
연구 개요
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Gangshu
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Lanzhou, Gangshu, 중국, 730000
- LanZhou University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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 |
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활성 비교기: 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 |
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다른: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline bone mineral density (BMD) at 12 months
기간: 0 and 12 months
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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
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Change from baseline bone mineral density (BMD) at 6 months
기간: 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
기간: 0 and 12 months
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BMC (g) determined by DXA at the left forearm and heel.
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0 and 12 months
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Change from baseline bone mineral contents (BMC) at 6 months
기간: 0 and 6 months
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BMC (g) determined by DXA at the left forearm and heel.
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0 and 6 months
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Change from baseline of bone-specific alkaline phosphatase at 12 months
기간: 0 and 12 months
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Bone turnover marker 1: Bone-specific alkaline phosphatase
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0 and 12 months
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Change from baseline of bone-specific alkaline phosphatase at 6 months
기간: 0 and 6 months
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Bone turnover marker 1: Bone-specific alkaline phosphatase
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0 and 6 months
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Change from baseline of osteocalcin at 12 months
기간: 0 and 12 months
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Bone turnover marker 2: osteocalcin
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0 and 12 months
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Change from baseline of osteocalcin at 6 months
기간: 0 and 6 months
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Bone turnover marker 2: osteocalcin
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0 and 6 months
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Change from baseline of C-terminal telopeptide of type I collagen at 12 months
기간: 0 and 12 months
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Bone turnover marker 3: C-terminal telopeptide of type I collagen
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0 and 12 months
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Change from baseline of C-terminal telopeptide of type I collagen at 6 months
기간: 0 and 6 months
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Bone turnover marker 3: C-terminal telopeptide of type I collagen
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0 and 6 months
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Change from baseline of tartrate resistant acid phosphatase at 12 months
기간: 0 and 12 months
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Bone turnover marker 4: tartrate resistant acid phosphatase
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0 and 12 months
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Change from baseline of tartrate resistant acid phosphatase at 6 months
기간: 0 and 6 months
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Bone turnover marker 4: tartrate resistant acid phosphatase
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0 and 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change from baseline body weight at 12 months
기간: 0 and 12 months
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Anthropometric indices: body weight
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0 and 12 months
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Change from baseline body height at 12 months
기간: 0 and 12 months
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Anthropometric indices: body height
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0 and 12 months
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Change from baseline biomarker of body growth at 12 months
기간: 0 and 12 months
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Biomarker of body growth: insulin-like growth factor 1
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0 and 12 months
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Change from baseline immune globulin M (Ig M）at 12 months
기간: 0 and 12 months
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Immune status: Blood Ig M
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0 and 12 months
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Change from baseline immune globulin G (Ig G）at 12 months
기간: 0 and 12 months
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Immune status: Blood Ig G
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0 and 12 months
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Change from baseline immune globulin G (Ig A）at 12 months
기간: 0 and 12 months
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Immune status: Blood Ig A
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0 and 12 months
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Change from baseline whit blood cell at 12 months
기간: 0 and 12 months
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Immune status: whit blood cell
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0 and 12 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Concentrations of blood total 25-hydroxide-vitamin D (25-OH-VD)
기간: 0, 6 and 12 months
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Serum 25-OH-VD
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0, 6 and 12 months
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Concentrations of blood parathyroid Hormone (PTH)
기간: 0, 6 and 12 months
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Serum PTH
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0, 6 and 12 months
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Nutritional status 1: Body weight
기간: 0, 4, 8 and 12 months
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Body weight (in kg)
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0, 4, 8 and 12 months
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Nutritional status 2: waist circumference
기간: 0, 4, 8 and 12 months
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Waist circumference (in cm)
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0, 4, 8 and 12 months
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Nutritional status 3: middle-arm circumference
기간: 0, 4, 8 and 12 months
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Middle-arm circumference (in cm)
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0, 4, 8 and 12 months
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Nutritional status 4: skinfold thickness
기간: 0, 4, 8 and 12 months
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Skinfold thickness (in mm)
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0, 4, 8 and 12 months
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Total consumption of milk and dairy food
기간: 0, 4, 8 and 12 months
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Total consumption of milk and dairy food (in ml/d)
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0, 4, 8 and 12 months
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Consumption of dietary energy
기간: 0, 4, 8 and 12 months
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Consumption of dietary energy (in kcal/d)
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0, 4, 8 and 12 months
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Consumption of dietary protein
기간: 0, 4, 8 and 12 months
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Consumption of dietary protein (in g/d)
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0, 4, 8 and 12 months
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Consumption of dietary calcium
기간: 0, 4, 8 and 12 months
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Consumption of dietary calcium (in mg/d)
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0, 4, 8 and 12 months
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Number of participants with treatment-related adverse events
기간: 0, 4, 8 and 12 months
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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
기간: 0 and 12 months
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Child behaviours: assessed by using a Child behavior Questionnaire-- parent version.
The minimum and maximum values: 26-78; higher scores mean worse outcome.
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0 and 12 months
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Physical activity
기간: 0, 4, 8 and 12 months
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Physical activity (in MET, h/week): assessed by a Child Physical Activity Questionnaire
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0, 4, 8 and 12 months
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Concentrations of serum calcium
기간: 0, 6 and 12 months
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Serum calcium (mmol/L)
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0, 6 and 12 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Yuming Chen, Ph.D., Sun Yat-sen University
- 연구 의자: Zhifu Zhao, M. Phil, Inner Mongolia Dairy Technology Research Institute Co., Ltd.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
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추가 정보
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