Milk Supplementation and Bone Health in Children

Sun Yat-sen University

Status: Unknown

Conditions: Bone Density Increased; Body Height

Treatments: Other: Control foods; Dietary Supplement: Regular milk; Dietary Supplement: Formula milk

Study type: Interventional

Funder types: Other

Identifiers

NCT05074836

SYSU-51000-20210723-0001

Details and patient eligibility

About

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.

Enrollment: 254 estimated patients

Sex: All

Ages: 48 to 83 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

254 participants in 3 patient groups

Formula Milk

Experimental group

Description:

Formula milk designed for young children aged over 3 years; Dosage: 195 ml/time; Frequence: 2 times /day; Duration: 12 months

Treatment:

Dietary Supplement: Formula milk

Regular milk

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Regular milk

Control foods

Other group

Description:

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

Treatment:

Other: Control foods