Milk Supplementation and Bone Health in Children

NCT05074836 | Unknown

• 1 other identifier: SYSU-51000-20210723-0001
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bone Density Increased; Body Height

Keywords

milk; bone health; body growth; young children

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (7)

• Change from baseline body weight at 12 months

  0 and 12 months

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

  0 and 12 months

Other Outcomes (14)

• Concentrations of blood total 25-hydroxide-vitamin D (25-OH-VD)

  0, 6 and 12 months

• Concentrations of blood parathyroid Hormone (PTH)

  0, 6 and 12 months

• Nutritional status 1: Body weight

  0, 4, 8 and 12 months

Study Arms (3)

Formula Milk

EXPERIMENTAL

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

Regular milk

ACTIVE COMPARATOR

Regular milk (pure milk); Dosage: 195 ml/time; Frequence: 2 times /day; Duration: 12 months

Dietary Supplement: Regular milk

Control foods

OTHER

Grain foods: e.g., bread; Dosage: 20-40 g/time; Frequence: 2 times /day; Duration: 12 months

Other: Control foods

Interventions

Formula milk DIETARY_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

Formula Milk

Regular milk DIETARY_SUPPLEMENT

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

Regular milk

Control foods OTHER

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

Control foods

Eligibility Criteria

• Age: 48 Months - 83 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged between 4-6 years;
• female and male
• Can be enrolled into kindergarten/school as a normal child.
• Be willing to drinking milk daily.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• LanZhou University: collaborator

Study Sites (1)

Lanzhou University

Lanzhou, Gangshu, 730000, China

Location

Related Publications (1)

• Zhao ZF, Li BY, He Q, Hao JY, Zhang KS, Zhang B, Hu W, Feng HT, Szeto IM, Chen YM, Zhang GX, Tang XY. Impact of dairy supplementation on bone acquisition in children's limbs: a 12-month cluster-randomized controlled trial and meta-analysis. Arch Osteoporos. 2024 Jul 24;19(1):65. doi: 10.1007/s11657-024-01422-2.

  PMID: 39043915 DERIVED

MeSH Terms

Conditions

Osteosclerosis

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Yuming Chen, Ph.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Zhifu Zhao, M. Phil

  Inner Mongolia Dairy Technology Research Institute Co., Ltd.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The two milk products have the same-looking package and similar taste.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: October 12, 2021
• Study Start: September 3, 2021
• Primary Completion: October 30, 2022
• Study Completion: December 30, 2022
• Last Updated: October 12, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)