NCT07256314

Brief Summary

The study aims to understand the current situation of bone health in the Gannan Tibetan primary school student population, to explore the relationship between nutrition, intestinal microorganisms and bone health, to analyze the main factors affecting bone health from the perspective of nutrition and intestinal microecology, and to provide theoretical basis for the promotion and improvement of bone health in Tibetan primary school students.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
431

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 1, 2025

Completed
Last Updated

December 5, 2025

Status Verified

November 1, 2025

Enrollment Period

1.5 years

First QC Date

November 20, 2025

Last Update Submit

November 29, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Dietary Characteristics

    Dietary data were collected using a food frequency questionnaire (FFQ) to analyze dietary patterns and nutrient intake.

    Day 1

  • Bone density test

    In this study, a peripheral dual-energy X-ray absorptiometry (EXA-PRESTO) was used to measure the bone density of the non-dominant forearm of the subjects.

    Day1

  • Fecal sample microbiological testing and analysis

    This study entrusted Tianhao Gene Technology Co., Ltd. to perform the intestinal microbiome Accu16STM (16S rRNA absolute quantitative sequencing). The main research processes include DNA extraction, PCR amplification, library construction, and sequencing.

    Day 1

Study Arms (1)

Good Bone Density group and normal bone density group

Other: No Intervention: Observational Cohort

Interventions

No Intervention

Good Bone Density group and normal bone density group

Eligibility Criteria

Age6 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

This study is based on a cross-sectional design. Two schools were selected: one rural primary school in Xiahe County, Gannan Tibetan Autonomous Prefecture, and one urban primary school in Hezuo City, Gansu Province. Within the selected schools, a stratified random cluster sampling method was used to randomly select one class from each grade as the study subjects.

You may qualify if:

  • Tibetan primary school students currently enrolled in schools in Gannan Tibetan Autonomous Prefecture;
  • Willing to participate and able to cooperate in completing bone density measurements;

You may not qualify if:

  • Suffering from skeletal system diseases, metabolic disorders, or endocrine diseases;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lanzhou university

Lanzhou, Gansu, 730000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Faecal samples

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 1, 2025

Study Start

October 10, 2023

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

December 5, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations