An interventional study of Vitamin D3 in Major Depression and Vitamin D Deficiency, sponsored by Mackay Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 10 Years to 24 Years. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Mackay Memorial Hospital · Not applicable, Interventional, and Health services research
The current study is designed as a prospective partially randomized patient preference (PRPP) trial and recruit psychiatric outpatients or inpatients. Participants who agree to receive randomization will be randomly assigned into a supplementation or placebo group, after stratification for pre-intervention vitamin D status (12-20 ng/mL or \<12 ng/mL) and depression status (HDRS-17 ≥ 17 or \< 17). Participants who decline randomization but agree to receive follow-up in the observational cohort choose their preferred method (either 4800 IU vitamin D3 per day, or usual care without supplementation). Severity of depression, any change of medication, and side effect will be assessed at baseline and at 2-week intervals for 8 weeks. Serum levels of 25(OH)D, C-Reactive protein (CRP) and 12 cytokines, anthropometrical measurements, dietary intake, physical activity and sun exposure will be assessed at baseline and post-intervention. Additionally, serum levels of 25(OH)D will be assessed at 4 weeks to ensure its safety level.
Investigators will conduct a partially randomized patient preference (PRPP) trial and recruit psychiatric outpatients or inpatients. Inclusion criteria are young people aged 10 to 24, fulfilling the DSM-V criteria of major depressive disorder (MDD) with scores of HDRS-17≥10, psychotropic medication have been kept unchanged for a month and will remain unchanged during intervention period, and serum 25-hydroxycholecalciferol (25-OH-D) levels lower than 20 ng/ml. Exclusion criteria are comorbid with organic mental disorders, alcohol or substance use disorders, schizophrenia, delusion disorder, bipolar disorder, autistic spectrum disorder, anorexia nervosa, and IQ less than 70; endocrine disorders including diabetes, thyroid and parathyroid disorder; serious neurological disorders including epilepsy, severe traumatic brain injury, and neurodegenerative conditions; liver disease, kidney disease, heart disease or other serious health conditions; use drug interfering with vitamin D metabolism.
Participants who agree to receive randomization will be randomly assigned into a supplementation or placebo group, after stratification for pre-intervention vitamin D status (12-20 ng/mL or \<12 ng/mL) and depression status (HDRS-17 ≥ 17 or \< 17). Supplementation arm will receive oral dose 4800 IU vitamin D3 per day (three soft capsules of 800 IU vitamin D, twice a day) and placebo arm will receive placebo every day (three soft capsules with identical appearance, twice a day) for 8 weeks. Both groups continue to receive standard psychiatric care by child psychiatrists. Randomization and allocation will be concealed from researchers, participants and treating physicians. Participants who decline randomization but agree to receive follow-up in the observational cohort choose their preferred method (either 4800 IU vitamin D3 per day, or usual care without supplementation). Severity of depression, any change of medication, and side effect will be assessed at baseline and at 2-week intervals for 8 weeks. Serum levels of 25(OH)D, CRP and 12 cytokines, anthropometrical measurements, dietary intake, physical activity and sun exposure will be assessed at baseline and post-intervention. Additionally, serum levels of 25(OH)D will be assessed at 4 weeks to ensure its safety level.
772 studies on the registry are indexed under Vitamin D Deficiency; 61 are open to participants now.
This study's enrollment of 142 is above the median of 77 across 564 interventional studies indexed under Vitamin D Deficiency.
Browse Vitamin D Deficiency studies →Mackay Memorial Hospital is the lead sponsor of 118 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
1.endocrine disorders
2.serious neurological disorders
7.severe mental disorders
8.Patients use drugs or herbals interfering with vitamin D metabolisms
Subjects will be randomly assigned to receive a daily vitamin D supplementation (4800IU daily) for 8 weeks
Dietary Supplement: Vitamin D3
Subjects will be randomly assigned to receive a placebo for 8 weeks.
Subjects with a strong preference to receive a daily vitamin D supplementation (4800IU daily) for 8 weeks.
Dietary Supplement: Vitamin D3
Subjects with a strong preference to receive usual care (not receiving vitamin D supplements) for 8 weeks.
Vitamin D3 4800IU daily
Change of total score of 17-item Hamilton Depression Rating Scale (HDRS-17)
17-item Hamilton Depression Rating Scale is an interview-based instrument for rating the overall levels of severity of the symptoms of depression and the response to treatment. Each item is rated from 0 to 4 or 0 to 2; the scores correspond to increases in severity. Total scores range from 0 to 52.
Time frame: baseline and at 8 weeks (the end of intervention)
17-item Hamilton Depression Rating Scale (HDRS-17)
HDRS-17 is measured totally 5 times, at week 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks. The change in total HDRS-17 score between baseline and the intermediate 2-week, 4-week, 6-week follow-ups were considered secondary outcomes measures.
Time frame: change from baseline score at 8 weeks
Response rate of 17-item Hamilton Depression Rating Scale (HDRS-17)
Response rate is defined as a reduction in HDRS-17 total score of at least 50 percent relative to the beginning of the randomized phase (baseline).
Time frame: at 2 weeks, 4 weeks, 6 weeks, 8 weeks
Remission rate of 17-item Hamilton Depression Rating Scale (HDRS-17)
Remission rate is defined as an absolute HDRS-17 total score of ≤ 7 at each follow-up assessment.
Time frame: at week 2, 4, 6, 8 weeks
End of intervention remission rate in17-item Hamilton Depression Rating Scale (HDRS-17)
Remission rate is defined as an absolute HDRS-17 total score of ≤ 7 at the end of treatment (8 week after intervention).
Time frame: at 8 weeks
Change of total score of Beck Depression Inventory-Second Edition
Beck Depression Inventory is a 21-item self-report measure, scored from 0 to 3 (range 0-63), and greater scores indicate severe depression symptoms.Beck Depression Inventory (BDI) is measured totally 5 times, at week 0, 2 weeks, 4 weeks, 6 weeks, 8 weeks. The change in total BDI score between baseline and each of follow-ups (2-week, 4-week, 6-week, 8-week follow-ups) were considered secondary outcomes measures.
Time frame: change from baseline score at 8 weeks
Significant change (mean±SD) in vitamin D status
serum levels of 25(OH)D, units of measure is ng/mL
Time frame: baseline and at 8 weeks
Change of total score of Generalized Anxiety Disorder Questionnaire
Generalized Anxiety Disorder Questionnaire is a 7-item self-report measure, scored from 0 to 3 (range 0-21), and greater scores indicate severe anxiety symptoms.
Time frame: baseline and at 8 weeks (the end of intervention)
Significant change (mean±SD) in serum concentration of hs-CRP
The serum concentration of hs-CRP (mg/L) will be measured at baseline and 8 weeks after intervention. Normal range is \<0.3 mg/L.
Time frame: baseline and 8 weeks after intervention
Significant change (mean±SD) in serum concentration of cytokine targets
The serum concentration of cytokine targets (IL-1β, IL-2, IL-6, IL-12, IL-15, TNF-α, IFN-γ, IL-4, IL-5, IL-13, IL-10, IL-1Ra) (unit: pg/mL) will be measured at baseline and 8 weeks after intervention.
Time frame: baseline and 8 weeks after intervention
Plan to share: No
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Mackay Memorial Hospital