Evaluating vitamin D's effect on depression in Chinese adolescents
Effect of Vitamin D Supplementation on Depressive Symptoms in Chinese Adolescents
This study is testing if taking vitamin D3 can help Chinese teenagers with low vitamin D levels feel less depressed over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 310 (estimated) |
| Sex | All |
| Sponsor | Anhui Medical University Academic / other |
| Locations | 2 sites (Anqing, Anhui and 1 other locations) |
| Trial ID | NCT06247930 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the impact of vitamin D3 supplementation on depressive symptoms in Chinese adolescents who exhibit vitamin D deficiency and elevated depressive symptoms. A total of 310 participants from two middle schools will be randomly assigned to receive either vitamin D3 capsules or a placebo, alongside mental health education. The primary outcome will be the change in depressive symptoms measured at baseline and after 12 weeks of intervention. The study will compare the effectiveness of vitamin D3 supplementation against a placebo in reducing depressive symptoms.
Who should consider this trial
Good fit: Ideal candidates are Chinese adolescents in grades 7 and 8 with mild to moderate depressive symptoms and low serum vitamin D levels.
Not a fit: Patients with serious health conditions, recent use of anti-psychotic treatments, or significant suicidal ideation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel and accessible treatment option for adolescents suffering from depression linked to vitamin D deficiency.
How similar studies have performed: While there have been studies exploring vitamin D's role in mental health, this specific approach targeting adolescents with depressive symptoms is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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., major psychiatric disorders, 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.
Where this trial is running
Anqing, Anhui and 1 other locations
- Susong County Zhenxing School — Anqing, Anhui, China (Recruiting)
- Suzon County Guangfu Middle School — Anqing, Anhui, China (Recruiting)
Study contacts
- Principal investigator: Puyu Su, Professor — Anhui Medical University
- Study coordinator: Puyu Su, PhD
- Email: supuyu@ahmu.edu.cn
- Phone: 8613856058551
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.