Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06247930
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-01-31
Brief Title:
An Evaluation of the Effect of Vitamin D Supplementation on Depressive Symptoms Among Chinese Adolescents
Sponsor:
Anhui Medical University
Organization:
Anhui Medical University
Study Overview
Official Title:
Effect of Vitamin D Supplementation on Depressive Symptoms in Chinese Adolescents
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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-II13 and serum 25OHD concentration of 12-20 ngmL Exclusion criteria are the use of anti-psychotic treatments or interventions in the past 3 months serious health conditions eg 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 plansattempts 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None