An Evaluation of the Effect of Vitamin D Supplementation on Depressive

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06247930
Study type	Interventional
Source	Anhui Medical University
Contact	Puyu Su, PhD
Phone	8613856058551
Email	supuyu@ahmu.edu.cn
Status	Recruiting
Phase	N/A
Start date	March 22, 2024
Completion date	December 22, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02909387` - Adapting Project UPLIFT for Blacks in Georgia	N/A
Completed	`NCT05702086` - Making SPARX Fly in Nunavut: Pilot Testing an E-intervention for Boosting Resilience Against Youth Depression	N/A
Terminated	`NCT04921332` - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD	N/A
Completed	`NCT03535805` - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances	N/A
Recruiting	`NCT06100146` - Effectiveness of Fortification With Folic Acid and Vitamin B12 Among Teenage Girls	N/A
Recruiting	`NCT03272230` - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System	N/A
Completed	`NCT03514355` - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms	N/A
Completed	`NCT05376397` - Testing THRIVE 365 for Black Sexual Minority Men (On The Daily)	N/A
Terminated	`NCT04367636` - The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19	N/A
Completed	`NCT04403126` - To Increase Psychological Well-being by the Implementation of Forgiveness Education	N/A
Recruiting	`NCT05078424` - Cognitive Behavioural Therapy for Youths With Depressive and Anxiety Symptoms in Hong Kong	N/A
Recruiting	`NCT06053775` - Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP)	N/A
Active, not recruiting	`NCT04084795` - Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia	N/A
Recruiting	`NCT04082052` - Evaluating and Predicting Response to a Single Session Intervention for Self-Dislike	N/A
Completed	`NCT04011540` - Digital Data in Mental Health Therapy	N/A
Not yet recruiting	`NCT06413849` - Telephone-coached "Graphic Narrative" Bibliotherapy for Dementia Caregivers	N/A
Not yet recruiting	`NCT03659591` - Triple Aim Psychotherapy: Aimed at Improving Patient Experience, Population Health, and Cost	N/A
Not yet recruiting	`NCT02133170` - "Mindfulness vs Psychoeducation in Bipolar Disorder"	N/A
Completed	`NCT02314390` - Group- Versus Individual-Mindfulness-Based Cognitive Therapy: a Randomized Trial	N/A
Completed	`NCT01628016` - The Effect of Attention Bias Modification Training on Reducing Depressive Symptoms	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms