Milk Supplementation and Bone Health in Children

Bone Density Increased Clinical Trial

Official title:

Effects of Yili Child Formula Milk on Bone Health in 4-6 Year Children: a 12-month Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05074836
• Other study ID #: SYSU-51000-20210723-0001
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 3, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: September 2021
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 254
• Est. completion date: December 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 48 Months to 83 Months

Eligibility

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.

Related Conditions & MeSH terms

• Body Height
• Bone Density Increased

Intervention

Dietary Supplement:
• Formula milk
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
• Regular milk
Brand name: Yili; Type: regular milk (pure milk); Dosage: 195ml*2/d; Intervention duration: 12 months

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

Locations

Country	Name	City	State
China	Lanzhou University	Lanzhou	Gangshu

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	LanZhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Concentrations of blood total 25-hydroxide-vitamin D (25-OH-VD)	Serum 25-OH-VD	0, 6 and 12 months
Other	Concentrations of blood parathyroid Hormone (PTH)	Serum PTH	0, 6 and 12 months
Other	Nutritional status 1: Body weight	Body weight (in kg)	0, 4, 8 and 12 months
Other	Nutritional status 2: waist circumference	Waist circumference (in cm)	0, 4, 8 and 12 months
Other	Nutritional status 3: middle-arm circumference	Middle-arm circumference (in cm)	0, 4, 8 and 12 months
Other	Nutritional status 4: skinfold thickness	Skinfold thickness (in mm)	0, 4, 8 and 12 months
Other	Total consumption of milk and dairy food	Total consumption of milk and dairy food (in ml/d)	0, 4, 8 and 12 months
Other	Consumption of dietary energy	Consumption of dietary energy (in kcal/d)	0, 4, 8 and 12 months
Other	Consumption of dietary protein	Consumption of dietary protein (in g/d)	0, 4, 8 and 12 months
Other	Consumption of dietary calcium	Consumption of dietary calcium (in mg/d)	0, 4, 8 and 12 months
Other	Number of participants with treatment-related adverse events	Adverse events : assessed by using questionnaires of medical conditions, medications related to milk intake	0, 4, 8 and 12 months
Other	Child behaviors	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
Other	Physical activity	Physical activity (in MET, h/week): assessed by a Child Physical Activity Questionnaire	0, 4, 8 and 12 months
Other	Concentrations of serum calcium	Serum calcium (mmol/L)	0, 6 and 12 months
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change from baseline of bone-specific alkaline phosphatase at 12 months	Bone turnover marker 1: Bone-specific alkaline phosphatase	0 and 12 months
Primary	Change from baseline of bone-specific alkaline phosphatase at 6 months	Bone turnover marker 1: Bone-specific alkaline phosphatase	0 and 6 months
Primary	Change from baseline of osteocalcin at 12 months	Bone turnover marker 2: osteocalcin	0 and 12 months
Primary	Change from baseline of osteocalcin at 6 months	Bone turnover marker 2: osteocalcin	0 and 6 months
Primary	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
Primary	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
Primary	Change from baseline of tartrate resistant acid phosphatase at 12 months	Bone turnover marker 4: tartrate resistant acid phosphatase	0 and 12 months
Primary	Change from baseline of tartrate resistant acid phosphatase at 6 months	Bone turnover marker 4: tartrate resistant acid phosphatase	0 and 6 months
Secondary	Change from baseline body weight at 12 months	Anthropometric indices: body weight	0 and 12 months
Secondary	Change from baseline body height at 12 months	Anthropometric indices: body height	0 and 12 months
Secondary	Change from baseline biomarker of body growth at 12 months	Biomarker of body growth: insulin-like growth factor 1	0 and 12 months
Secondary	Change from baseline immune globulin M (Ig M)at 12 months	Immune status: Blood Ig M	0 and 12 months
Secondary	Change from baseline immune globulin G (Ig G)at 12 months	Immune status: Blood Ig G	0 and 12 months
Secondary	Change from baseline immune globulin G (Ig A)at 12 months	Immune status: Blood Ig A	0 and 12 months
Secondary	Change from baseline whit blood cell at 12 months	Immune status: whit blood cell	0 and 12 months