NCT06247930

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

Effect of Vitamin D Supplementation on Depressive Symptoms in Chinese Early Adolescents

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 406 (actual)
• Sponsor: Anhui Medical University · Academic / Other
• Sex: All
• Age: 10 Years – 15 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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.
DIETARY_SUPPLEMENT	Vitamin D3 placebo	Three capsules for 6 weeks, followed by one capsule for 6 weeks.
BEHAVIORAL	Mental health education	The mental health education consists of providing a brochure and videos containing information about mental health problems.

Timeline

• Start date: 2024-03-19
• Primary completion: 2025-04-01
• Completion: 2025-06-24
• First posted: 2024-02-08
• Last updated: 2025-07-02

Locations

2 sites across 1 country: China