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Bone Density IncreasedNCT05074836

Milk Supplementation and Bone Health in Children

A study testing Formula milk and Regular milk in people with Bone Density Increased and Body Height, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 48 to 83 monthsHealthy volunteers can take part
Conditions the study is for
Bone Density Increased, Body Height
What is being tested?
Formula milk and Regular milk
Could I receive a placebo?
No, everyone receives an active treatment
How many people
254 participants
Where
1 siteChina
Study dates
3 Sep 2021to 30 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 48 to 83 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

China1 site

  • Lanzhou University

    Lanzhou, Gangshu, 730000

Other trials in China

About this study

Official title: 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.

Read more

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.

Being tested
Formula milk, Regular milk, Control foods
Keywords
milk, bone health, body growth, young children
Medical subject headings
Osteosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Formula milkDietary 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

  • Regular milkDietary supplement

    Brand name: Yili；

    Type: regular milk (pure milk);

    Dosage: 195ml*2/d;

    Intervention duration: 12 months

  • Control foodsOther

    Brand: N/A;

    Food type: grain foods (e.g., bread);

    Dosage: 20-40g * 2/d grain foods

    Intervention duration: 12 months

Study groups in NCT05074836
Study groupRoleWhat they receive
Formula MilkExperimentalFormula milk designed for young children aged over 3 years; Dosage: 195 ml/time; Frequence: 2 times /day; Duration: 12 months
Receives: Dietary Supplement: Formula milk
Regular milkActive comparatorRegular milk (pure milk); Dosage: 195 ml/time; Frequence: 2 times /day; Duration: 12 months
Receives: Dietary Supplement: Regular milk
Control foodsOtherGrain foods: e.g., bread; Dosage: 20-40 g/time; Frequence: 2 times /day; Duration: 12 months
Receives: Other: Control foods

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 0 and 12 months

  2. Change from baseline bone mineral density (BMD) at 6 months

    BMD (g/cm2) determined by DXA at the left forearm and heel

    Measured: 0 and 6 months

  3. Change from baseline bone mineral contents (BMC) at 12 months

    BMC (g) determined by DXA at the left forearm and heel.

    Measured: 0 and 12 months

  4. Change from baseline bone mineral contents (BMC) at 6 months

    BMC (g) determined by DXA at the left forearm and heel.

    Measured: 0 and 6 months

  5. Change from baseline of bone-specific alkaline phosphatase at 12 months

    Bone turnover marker 1: Bone-specific alkaline phosphatase

    Measured: 0 and 12 months

  6. Change from baseline of bone-specific alkaline phosphatase at 6 months

    Bone turnover marker 1: Bone-specific alkaline phosphatase

    Measured: 0 and 6 months

  7. Change from baseline of osteocalcin at 12 months

    Bone turnover marker 2: osteocalcin

    Measured: 0 and 12 months

  8. Change from baseline of osteocalcin at 6 months

    Bone turnover marker 2: osteocalcin

    Measured: 0 and 6 months

  9. 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

    Measured: 0 and 12 months

  10. 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

    Measured: 0 and 6 months

  11. Change from baseline of tartrate resistant acid phosphatase at 12 months

    Bone turnover marker 4: tartrate resistant acid phosphatase

    Measured: 0 and 12 months

  12. Change from baseline of tartrate resistant acid phosphatase at 6 months

    Bone turnover marker 4: tartrate resistant acid phosphatase

    Measured: 0 and 6 months

Secondary outcomes (7)

  1. Change from baseline body weight at 12 months

    Anthropometric indices: body weight

    Measured: 0 and 12 months

  2. Change from baseline body height at 12 months

    Anthropometric indices: body height

    Measured: 0 and 12 months

  3. Change from baseline biomarker of body growth at 12 months

    Biomarker of body growth: insulin-like growth factor 1

    Measured: 0 and 12 months

  4. Change from baseline immune globulin M (Ig M）at 12 months

    Immune status: Blood Ig M

    Measured: 0 and 12 months

  5. Change from baseline immune globulin G (Ig G）at 12 months

    Immune status: Blood Ig G

    Measured: 0 and 12 months

  6. Change from baseline immune globulin G (Ig A）at 12 months

    Immune status: Blood Ig A

    Measured: 0 and 12 months

  7. Change from baseline whit blood cell at 12 months

    Immune status: whit blood cell

    Measured: 0 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2021
  2. Study start3 Sep 2021
  3. Primary completion30 Oct 2022 (estimated)
  4. Study completion30 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
254 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05074836
Sponsor's protocol ID
SYSU-51000-20210723-0001
Status last verified
Sep 2021
First submitted
10 Sep 2021
Last updated
12 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Published data based on reasonable request.

Publications

  • 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.

    PubMed 39043915

Questions about this trial

What is this clinical trial studying?

A study testing Formula milk and Regular milk in people with Bone Density Increased and Body Height, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline bone mineral density (BMD) at 12 months (time frame: 0 and 12 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05074836, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.

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