An Evaluation of the Effect of Vitamin D Supplementation on Depressive Symptoms Among Chinese Early Adolescents

NCT ID: NCT06247930

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 406 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-19
• Study Completion Date: 2025-06-24

Brief Summary

The goal of this randomized controlled clinical trial is to investigate the effects of vitamin D3 supplementation on depression in Chinese early adolescents with elevated depressive symptoms and vitamin D deficiency. The main question it aims to answer whether vitamin D3 supplementation can reduce depressive symptoms.

Participants in the intervention group will receive vitamin D3 capsules and mental health education. The control group will receive vitamin D3 placebo and mental health education.

Researchers will compare the change in depressive symptoms from baseline to post-intervention at 12 weeks between the intervention and control groups.

Detailed Description

Investigators will conduct a randomized controlled trial to examine whether vitamin D3 supplementation can improve depressive symptoms. Participants will be recruited from two middle schools. Participants will be randomly assigned into a supplementation or placebo group. Supplementation arm will receive oral dose 2000 IU vitamin D3 per day for 6 weeks and followed by 800 IU per day for 6 weeks; placebo arm will receive placebo every day for 12 weeks. Both of these two groups will receive additional mental health education. For the first 6 weeks, vitamin D or placebo will be administrated every two weeks. For the next 6 weeks, vitamin D or placebo will be administrated every three weeks. The primary outcome of this study is to compare the change of depressive symptoms between supplementation or placebo group from pre- to post-intervention at 12 weeks.

Conditions

Depressive Symptoms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vitamin D3 + Mental Health Education

Vitamin D3: 2000 IU per day for 6 weeks (two capsules of 800 IU plus one capsule of 400 IU), followed by 800 IU (one capsule of 800 IU) per day for 6 weeks.

Mental Health Education: consists of providing a brochure and videos containing information about mental health problems.

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

2000 IU per day for 6 weeks (two capsules of 800 IU plus one capsule of 400 IU), followed by 800 IU (one capsule of 800 IU) per day for 6 weeks.

Mental health education

Intervention Type: BEHAVIORAL

The mental health education consists of providing a brochure and videos containing information about mental health problems.

Vitamin D3 placebo + Mental Health Education

Vitamin D3 placebo (i.e., soybean oil). Mental Health Education: consists of providing a brochure and videos containing information about mental health problems.

Group Type: PLACEBO_COMPARATOR

Vitamin D3 placebo

Intervention Type: DIETARY_SUPPLEMENT

Three capsules for 6 weeks, followed by one capsule for 6 weeks.

Mental health education

Intervention Type: BEHAVIORAL

The mental health education consists of providing a brochure and videos containing information about mental health problems.

Interventions

Vitamin D3

2000 IU per day for 6 weeks (two capsules of 800 IU plus one capsule of 400 IU), followed by 800 IU (one capsule of 800 IU) per day for 6 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3 placebo

Three capsules for 6 weeks, followed by one capsule for 6 weeks.

Intervention Type: DIETARY_SUPPLEMENT

Mental health education

The mental health education consists of providing a brochure and videos containing information about mental health problems.

Intervention Type: BEHAVIORAL

Other Intervention Names

Cholecalciferol; Soybean oil

Eligibility Criteria

Inclusion Criteria

1. 7th-9th students whose caregivers signed informed consents;

2. students with serum 25(OH)D concentrations below 20 ng/mL;

3. students with self-reported depressive symptoms (BDI-II score of 14 or higher)

Exclusion Criteria

1. students who are currently receiving or have used anti-psychotic treatments or interventions (including drugs and non-drugs) in the past 3 months;

2. students who have serious health conditions (e.g., organic or functional brain diseases, major psychiatric disorders, cardiovascular diseases, serious infectious diseases, chronic gastrointestinal diseases, and hepatic or renal diseases);

3. students who are currently taking or have taken vitamin D supplements in the past 3 months;

4. students with self-reported serious suicidal ideation, suicidal plans and attempts in the past 3 months;

5. students with intellectual disability;

6. students who are allergic to vitamin D or soybean oil components.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

Yuan Mengyuan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Puyu Su, Professor

Role: PRINCIPAL_INVESTIGATOR

Anhui Medical University

Locations

Susong County Guangfu Middle School

Anqing, Anhui, China

Susong County Zhenxing School

Anqing, Anhui, China

Countries

China

Other Identifiers

84230079

Identifier Type: -

Identifier Source: org_study_id