---
title: Milk Supplementation and Bone Health in Children
nct_id: NCT05074836
overall_status: UNKNOWN
phase: NA
sponsor: Sun Yat-sen University
study_type: INTERVENTIONAL
primary_condition: Bone Density Increased
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05074836.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05074836"
ct_last_update_post_date: 2021-10-12
last_seen_at: "2026-05-12T07:21:08.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT05074836](https://clinicaltrials.gov/study/NCT05074836)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 254
- **Lead Sponsor:** Sun Yat-sen University
- **Collaborators:** LanZhou University
- **Conditions:** Bone Density Increased, Body Height
- **Start Date:** 2021-09-03
- **Completion Date:** 2022-12-30
- **CT.gov Last Update:** 2021-10-12

## 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

- **Minimum age:** 48 Months
- **Maximum age:** 83 Months
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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.
```

## Arms

- **Formula Milk** (EXPERIMENTAL) — Formula milk designed for young children aged over 3 years;

Dosage: 195 ml/time;

Frequence: 2 times /day;

Duration: 12 months
- **Regular milk** (ACTIVE_COMPARATOR) — Regular milk (pure milk);

Dosage: 195 ml/time;

Frequence: 2 times /day;

Duration: 12 months
- **Control foods** (OTHER) — Grain foods: e.g., bread;

Dosage: 20-40 g/time;

Frequence: 2 times /day;

Duration: 12 months

## 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
- **Regular milk** (DIETARY_SUPPLEMENT) — Brand name: Yili；

Type: regular milk (pure milk);

Dosage: 195ml\*2/d;

Intervention duration: 12 months
- **Control foods** (OTHER) — Brand: N/A;

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

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

Intervention duration: 12 months

## Primary Outcomes

- **Change from baseline bone mineral density (BMD) at 12 months** _(time frame: 0 and 12 months)_ — BMD (g/cm2) determined by a dual energy x-ray absorptiometry (DXA) at the left forearm and heel
- **Change from baseline bone mineral density (BMD) at 6 months** _(time frame: 0 and 6 months)_ — BMD (g/cm2) determined by DXA at the left forearm and heel
- **Change from baseline bone mineral contents (BMC) at 12 months** _(time frame: 0 and 12 months)_ — BMC (g) determined by DXA at the left forearm and heel.
- **Change from baseline bone mineral contents (BMC) at 6 months** _(time frame: 0 and 6 months)_ — BMC (g) determined by DXA at the left forearm and heel.
- **Change from baseline of bone-specific alkaline phosphatase at 12 months** _(time frame: 0 and 12 months)_ — Bone turnover marker 1: Bone-specific alkaline phosphatase
- **Change from baseline of bone-specific alkaline phosphatase at 6 months** _(time frame: 0 and 6 months)_ — Bone turnover marker 1: Bone-specific alkaline phosphatase
- **Change from baseline of osteocalcin at 12 months** _(time frame: 0 and 12 months)_ — Bone turnover marker 2: osteocalcin
- **Change from baseline of osteocalcin at 6 months** _(time frame: 0 and 6 months)_ — Bone turnover marker 2: osteocalcin
- **Change from baseline of C-terminal telopeptide of type I collagen at 12 months** _(time frame: 0 and 12 months)_ — Bone turnover marker 3: C-terminal telopeptide of type I collagen
- **Change from baseline of C-terminal telopeptide of type I collagen at 6 months** _(time frame: 0 and 6 months)_ — Bone turnover marker 3: C-terminal telopeptide of type I collagen
- **Change from baseline of tartrate resistant acid phosphatase at 12 months** _(time frame: 0 and 12 months)_ — Bone turnover marker 4: tartrate resistant acid phosphatase
- **Change from baseline of tartrate resistant acid phosphatase at 6 months** _(time frame: 0 and 6 months)_ — Bone turnover marker 4: tartrate resistant acid phosphatase

## Secondary Outcomes

- **Change from baseline body weight at 12 months** _(time frame: 0 and 12 months)_
- **Change from baseline body height at 12 months** _(time frame: 0 and 12 months)_
- **Change from baseline biomarker of body growth at 12 months** _(time frame: 0 and 12 months)_
- **Change from baseline immune globulin M (Ig M）at 12 months** _(time frame: 0 and 12 months)_
- **Change from baseline immune globulin G (Ig G）at 12 months** _(time frame: 0 and 12 months)_
- **Change from baseline immune globulin G (Ig A）at 12 months** _(time frame: 0 and 12 months)_
- **Change from baseline whit blood cell at 12 months** _(time frame: 0 and 12 months)_

## Locations (1)

- Lanzhou University, Lanzhou, Gangshu, China

## Recent Field Changes (last 30 days)

- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.lanzhou university|lanzhou|gangshu|china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05074836.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05074836*  
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