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

NCT06247930 | Completed DMC

• 1 other identifier: 84230079
• Study Type: interventional
• Target: 406
• Locations: 1 country
• Sites: 2

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.

Conditions

Depressive Symptoms

Keywords

depressive symptoms; vitamin D

Outcome Measures

Primary Outcomes (1)

• Change in depressive symptom scores

  Depressive symptoms are evaluated by the Chinese version of Beck Depression Inventory (BDI-II-C). The measured outcome was the total BDI-II-C scores. Each of the 21 items can be scored as 0, 1, 2, or 3 points. The range for the BDI-II-C score is 0-63 points; higher scores indicate worse depressive symptoms. Change in BDI-II-C scores from pre to post-intervention were compared between randomized groups, which was the primary outcome of this study.

  From randomization to the end of intervention at 3 months

Secondary Outcomes (10)

• Depressive Symptoms Scores

  Baseline, 6, 9, 24 and 36 weeks

• Patient Health Questionnaire-9 Scores

  Baseline, 6, 9, 12, 24 and 36 weeks

• Sleep Quality Scores

  Baseline, 6, 12, 24 and 36 weeks

• Number of Participants with a Suicidal Ideation Event

  From randomization to the occurrence of the endpoint or to the end of evaluation at 12, 24 or 36 weeks.

• Anxiety Symptoms Scores

  Baseline, 6, 9, 12, 24 and 36 weeks

Other Outcomes (1)

• Irritability Scores

  Baseline, 12, 36 weeks

Study Arms (2)

Vitamin D3 + Mental Health Education

EXPERIMENTAL

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.

Dietary Supplement: Vitamin D3; Behavioral: Mental health education

Vitamin D3 placebo + Mental Health Education

PLACEBO COMPARATOR

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

Dietary Supplement: Vitamin D3 placebo; Behavioral: Mental health education

Interventions

Vitamin D3 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.

Also known as: Cholecalciferol

Vitamin D3 + Mental Health Education

Vitamin D3 placebo DIETARY_SUPPLEMENT

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

Also known as: Soybean oil

Vitamin D3 placebo + Mental Health Education

Mental health education BEHAVIORAL

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

Vitamin D3 + Mental Health Education; Vitamin D3 placebo + Mental Health Education

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• th-9th students whose caregivers signed informed consents;
• students with serum 25(OH)D concentrations below 20 ng/mL;
• students with self-reported depressive symptoms (BDI-II score of 14 or higher)

You may not qualify if:

• students who are currently receiving or have used anti-psychotic treatments or interventions (including drugs and non-drugs) in the past 3 months;
• 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);
• students who are currently taking or have taken vitamin D supplements in the past 3 months;
• students with self-reported serious suicidal ideation, suicidal plans and attempts in the past 3 months;
• students with intellectual disability;
• students who are allergic to vitamin D or soybean oil components.

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (2)

Susong County Guangfu Middle School

Anqing, Anhui, 246500, China

Location

Susong County Zhenxing School

Anqing, Anhui, 246500, China

Location

MeSH Terms

Conditions

Depression

Interventions

Cholecalciferol; Soybean Oil

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Dietary Fats, Unsaturated; Dietary Fats; Fats; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Puyu Su, Professor

  Anhui Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 8, 2024
• Study Start: March 19, 2024
• Primary Completion: April 1, 2025
• Study Completion: June 24, 2025
• Last Updated: July 2, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)