Clinical trial NCT05074836: Milk Supplementation and Bone Health in Children
Official title: Effects of Yili Child Formula Milk on Bone Health in 4-6 Year Children: a 12-month Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Density Increased
Body Height
Keywords: milk
bone health
body growth
young children
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: LanZhou University
First posted: 2021-10-12
Enrollment: 254
Sex: ALL
Minimum age (years): 48
Maximum age (years): 83
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline bone mineral density (BMD) at 12 months
timeFrame: 0 and 12 months
measure: Change from baseline bone mineral density (BMD) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline bone mineral contents (BMC) at 12 months
timeFrame: 0 and 12 months
measure: Change from baseline bone mineral contents (BMC) at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline of bone-specific alkaline phosphatase at 12 months
timeFrame: 0 and 12 months
measure: Change from baseline of bone-specific alkaline phosphatase at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline of osteocalcin at 12 months
timeFrame: 0 and 12 months
measure: Change from baseline of osteocalcin at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline of C-terminal telopeptide of type I collagen at 12 months
timeFrame: 0 and 12 months
measure: Change from baseline of C-terminal telopeptide of type I collagen at 6 months
timeFrame: 0 and 6 months
measure: Change from baseline of tartrate resistant acid phosphatase at 12 months
timeFrame: 0 and 12 months
measure: Change from baseline of tartrate resistant acid phosphatase at 6 months
timeFrame: 0 and 6 months
Secondary outcomes:
measure: Change from baseline body weight at 12 months
timeFrame: 0 and 12 months
measure: Change from baseline body height at 12 months
timeFrame: 0 and 12 months
measure: Change from baseline biomarker of body growth at 12 months
timeFrame: 0 and 12 months
measure: Change from baseline immune globulin M (Ig M）at 12 months
timeFrame: 0 and 12 months
measure: Change from baseline immune globulin G (Ig G）at 12 months
timeFrame: 0 and 12 months
measure: Change from baseline immune globulin G (Ig A）at 12 months
timeFrame: 0 and 12 months
measure: Change from baseline whit blood cell at 12 months
timeFrame: 0 and 12 months
Other outcomes:
measure: Concentrations of blood total 25-hydroxide-vitamin D (25-OH-VD)
timeFrame: 0, 6 and 12 months
measure: Concentrations of blood parathyroid Hormone (PTH)
timeFrame: 0, 6 and 12 months
measure: Nutritional status 1: Body weight
timeFrame: 0, 4, 8 and 12 months
measure: Nutritional status 2: waist circumference
timeFrame: 0, 4, 8 and 12 months
measure: Nutritional status 3: middle-arm circumference
timeFrame: 0, 4, 8 and 12 months
measure: Nutritional status 4: skinfold thickness
timeFrame: 0, 4, 8 and 12 months
measure: Total consumption of milk and dairy food
timeFrame: 0, 4, 8 and 12 months
measure: Consumption of dietary energy
timeFrame: 0, 4, 8 and 12 months
measure: Consumption of dietary protein
timeFrame: 0, 4, 8 and 12 months
measure: Consumption of dietary calcium
timeFrame: 0, 4, 8 and 12 months
measure: Number of participants with treatment-related adverse events
timeFrame: 0, 4, 8 and 12 months
measure: Child behaviors
timeFrame: 0 and 12 months
measure: Physical activity
timeFrame: 0, 4, 8 and 12 months
measure: Concentrations of serum calcium
timeFrame: 0, 6 and 12 months
Locations:
city: Lanzhou
country: China
facility: Lanzhou University
state: Gangshu
Study officials:
affiliation: Sun Yat-sen University
name: Yuming Chen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inner Mongolia Dairy Technology Research Institute Co., Ltd.
name: Zhifu Zhao, M. Phil
role: STUDY_CHAIR
References: