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Prospective Randomized Controlled Trial on the Effect of Long-term Intake of Pasteurized Milk on Bone Growth and Development in Children and Adolescents

Study on the Regulation of Children's Bone Development by Nutrients in Milk

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127284
Enrollment
Unknown
Registered
2026-06-29
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Nutritional Support

Interventions

Long-term Dairy Intake Group:Long-term consumption of dairy products in the regular diet.
No Dairy Intake Group:In the study, individuals who do not have a habit of consuming dairy products were identified and recruited through dietary surveys.

Sponsors

Institute of Food and Nutrition Development, Ministry of Agriculture
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Age: Minors (under 18 years old) who are willing to actively participate in this study, and whose guardians and themselves can cooperate to complete at least 12 months of long-term pasteurized milk intake, follow-up testing throughout the period, as well as baseline and mid-term growth and development monitoring. As a group in the growth and development stage, minors' bone density, height growth, and other growth indicators are still dynamically changing, making them suitable for long-term intervention and growth and development monitoring research. 2. Gender: Both males and females are eligible. 3. Participants must truthfully report whether they have consumed dairy products regularly in the past three months. If so, detailed information on the type and frequency of intake must be provided. They should not have taken calcium supplements, vitamin D supplements, or medications affecting bone development (such as corticosteroids) to avoid interfering with the experimental results of long-term pasteurized milk intake and growth and development monitoring data. Upon enrollment, baseline growth and development monitoring must be completed, including height, bone density (a core indicator of bone quality), and bone age assessment, to establish a personal growth and development record. 4. Baseline Core Indicators: Upon enrollment, height and BMI must be included as fundamental baseline indicators, with measurements completed and recorded to assess the basic growth and development status of minors. Bone density and epiphyseal line assessments should be included based on research conditions when feasible but are not mandatory. These provide a baseline reference for evaluating long-term intervention effects and mid-term monitoring. All baseline indicators must fall within the normal range for minors of the same age and gender, with no significant growth and development abnormalities, ensuring consistency in the baseline characteristics of the study subjects. 5. Guardians must possess good communication skills and compliance, enabling them to fully cooperate throughout the study. This includes supervising and recording daily pasteurized milk intake, completing regular follow-ups and indicator testing, as well as baseline and mid-term growth and development monitoring (height, bone density, and bone age reassessment). The family must be able to consistently provide the pasteurized milk required for the intervention (or it will be uniformly supplied by the research team). 6. Guardians must voluntarily sign an informed consent form, clearly understanding that they are required to cooperate with at least 12 months of long-term monitoring, follow-ups, and baseline and mid-term growth and development monitoring. Children (=6 years old) must also sign an informed consent form (voluntary participation) and may withdraw at any time without affecting their health.

Exclusion criteria

Exclusion criteria: 1. Allergy History: Individuals allergic to milk, dairy products, or any component of pasteurized milk (e.g., milk fat, lactose). 2. Disease Factors: Individuals with congenital bone diseases (e.g., rickets, congenital hip dysplasia), endocrine disorders (e.g., thyroid dysfunction, growth hormone deficiency), liver or kidney diseases, chronic diarrhea, inflammatory bowel disease, or other conditions that may affect bone growth/development or nutrient absorption. 3. Medication/Supplement Factors: Individuals who have taken long-term calcium supplements, vitamin D supplements, hormones, antibiotics, etc., within the past three months, which may affect bone metabolism or experimental results. 4. Nutritional Abnormalities: Individuals with severe malnutrition, obesity (BMI >= the 95th percentile for age and gender), or wasting (BMI <= the 5th percentile for age and gender), which may affect bone development. 5. Bone Density Abnormalities: Individuals with baseline bone density findings indicating osteoporosis or osteopenia, or a history of fractures (within the past year). 6. Others: Individuals who do not voluntarily sign the informed consent form; guardians with poor compliance; inability to cooperate with follow-ups and testing; children with severe behavioral problems preventing cooperation; or individuals with unstable long-term residence who may withdraw from the study prematurely.

Design outcomes

Primary

MeasureTime frame
Height;Epiphyseal Line/Status;Bone Density/Mineral Content;Diet;

Secondary

MeasureTime frame
Gut Microbiota;BMI;

Countries

China

Contacts

Public ContactGuangxu Ren

Institute of Food and Nutrition Development, Ministry of Agriculture

renguangxu@caas.cn+86 182 1067 2910

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026