Clinical trial NCT06247930: An Evaluation of the Effect of Vitamin D Supplementation on Depressive Symptoms Among Chinese Adolescents
Official title: Effect of Vitamin D Supplementation on Depressive Symptoms in Chinese Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Symptoms
Keywords: depressive symptoms
vitamin D
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2024-02-08
Enrollment: 310
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled clinical trial is to investigate the effects of vitamin D3 supplementation on depression in Chinese 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. A total of 310 participants will be recruited from two middle schools. Inclusion criteria are grades 7th and 8th students whose caregivers signed informed consents, self-reported mild and moderate depressive symptoms with scores of BDI-II\>13, and serum 25(OH)D concentration of 12-20 ng/mL. Exclusion criteria are the use of anti-psychotic treatments or interventions in the past 3 months; serious health conditions (e.g., major psychiatric disorders, serious infectious diseases, chronic gastrointestinal diseases, and hepatic or renal diseases); the use of vitamin D supplements in the past 3 months; self-reported suicidal plans/attempts in the past 3 months; intellectual disability. 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.

Eligibility 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.

Primary outcomes:
measure: Change in depressive symptom scores
timeFrame: From randomization to the end of intervention at 3 months
Secondary outcomes:
measure: Depressive Symptoms Scores
timeFrame: Baseline, 2, 4, 6, 9, 24 and 36 weeks
measure: Patient Health Questionnaire-9 Scores
timeFrame: Baseline, 2, 4, 6, 9, 12, 24 and 36 weeks
measure: Sleep Quality Scores
timeFrame: Baseline, 6, 12, 24 and 36 weeks
measure: Number of Participants with a Suicidal Ideation Event
timeFrame: From randomization to the occurrence of the endpoint or to the end of evaluation at 12, 24 or 36 weeks.
measure: Anxiety Symptoms Scores
timeFrame: Baseline, 2, 4, 6, 9, 12, 24 and 36 weeks
measure: Psychological Resilience Scores
timeFrame: Baseline, 6, 12, 24 and 36 weeks
measure: Hopelessness Scores
timeFrame: Baseline, 2, 4, 6, 9, 12, 24 and 36 weeks
measure: Emotional and Behavioral Problems Scores
timeFrame: Baseline, 6, 12, 24, 36 weeks
measure: Loneliness Scores
timeFrame: Baseline, 6, 12, 24, 36 weeks
measure: Emotional Regulation Ability Scores
timeFrame: Baseline, 6, 12, 24, 36 weeks
measure: Health-related Quality of Life Scores
timeFrame: Baseline, 12, 24, 36 weeks
Other outcomes:
measure: Aggression Scores
timeFrame: Baseline, 12, 24, 36 weeks
measure: Irritability Scores
timeFrame: Baseline, 12, 24, 36 weeks
Locations:
city: Anqing
country: China
facility: Susong County Zhenxing School
state: Anhui
city: Anqing
country: China
facility: Suzon County Guangfu Middle School
state: Anhui
Study officials:
affiliation: Anhui Medical University
name: Puyu Su, Professor
role: PRINCIPAL_INVESTIGATOR
References: