- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04898725
Effects of Vitamin D Supplementation on Depression and Inflammatory Markers
Effects of Vitamin D Supplementation on Depression and Inflammatory Markers in Adolescent and Youth With Major Depression and Vitamin D-deficiency: a Partially Randomized Preference Trial in Taiwan
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hui-Chun Huang, PhD
- Phone Number: 3055 +886-2-28094661
- Email: aihch@mmh.org.tw
Study Locations
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-
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Taipei, Taiwan
- Recruiting
- Mackay Memorial Hospital
-
Contact:
- Hui-Chun Huang, PhD
- Phone Number: 3055 +886-2-28094661
- Email: aihch@mmh.org.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 1.patients who attend psychiatric outpatient clinics or who are admitted to the psychiatric inpatient ward at the above sites.
- 2.clinical diagnosis of depression-related disorders and scores of HDRS-17 ≥ 10.
- 3.psychotropics have been kept unchanged for at least a month.
- 4.aged 10 to 24.
- 5.serum 25-hydroxycholecalciferol (25-OH-D) levels lower than 20 ng/ml.
Exclusion Criteria:
1.endocrine disorders
- including diabetes
- thyroid
- parathyroid disorder.
2.serious neurological disorders
- epilepsy
- severe traumatic brain injury
- neurodegenerative conditions
- 3.liver disease
- 4.kidney disease
- 5.heart disease
- 6.other serious health conditions.
7.severe mental disorders
- Organic mental disorders
- Alcohol or substance use disorders active within 3 months
- Schizophrenia
- Delusional disorder
- Psychotic disorders not elsewhere classified.
- Bipolar disorder.
- Autistic spectrum disorder.
- Anorexia nervosa.
- Mental retardation with IQ less than 70.
- High violence or suicide risk.
8.Patients use drugs or herbals interfering with vitamin D metabolisms
- phenobarbital
- phenytoin
- anti-tuberculosis drugs
- thiazide diuretics.
- 9.Pregnant or expect to be pregnant during study participation.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vit D Group (randomized)
Subjects will be randomly assigned to receive a daily vitamin D supplementation (4800IU daily) for 8 weeks
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Vitamin D3 4800IU daily
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No Intervention: Control Group (randomized)
Subjects will be randomly assigned to receive a placebo for 8 weeks.
|
|
Experimental: Preference Vit D Group (non-randomized)
Subjects with a strong preference to receive a daily vitamin D supplementation (4800IU daily) for 8 weeks.
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Vitamin D3 4800IU daily
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No Intervention: Preference no Vit D Group (non-randomized)
Subjects with a strong preference to receive usual care (not receiving vitamin D supplements) for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of total score of 17-item Hamilton Depression Rating Scale (HDRS-17)
Time Frame: baseline and at 8 weeks (the end of intervention)
|
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.
|
baseline and at 8 weeks (the end of intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
17-item Hamilton Depression Rating Scale (HDRS-17)
Time Frame: change from baseline score at 8 weeks
|
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.
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change from baseline score at 8 weeks
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Response rate of 17-item Hamilton Depression Rating Scale (HDRS-17)
Time Frame: at 2 weeks, 4 weeks, 6 weeks, 8 weeks
|
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).
|
at 2 weeks, 4 weeks, 6 weeks, 8 weeks
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Remission rate of 17-item Hamilton Depression Rating Scale (HDRS-17)
Time Frame: at week 2, 4, 6, 8 weeks
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Remission rate is defined as an absolute HDRS-17 total score of ≤ 7 at each follow-up assessment.
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at week 2, 4, 6, 8 weeks
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End of intervention remission rate in17-item Hamilton Depression Rating Scale (HDRS-17)
Time Frame: at 8 weeks
|
Remission rate is defined as an absolute HDRS-17 total score of ≤ 7 at the end of treatment (8 week after intervention).
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at 8 weeks
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Change of total score of Beck Depression Inventory-Second Edition
Time Frame: change from baseline score at 8 weeks
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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.
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change from baseline score at 8 weeks
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Significant change (mean±SD) in vitamin D status
Time Frame: baseline and at 8 weeks
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serum levels of 25(OH)D, units of measure is ng/mL
|
baseline and at 8 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of total score of Generalized Anxiety Disorder Questionnaire
Time Frame: baseline and at 8 weeks (the end of intervention)
|
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.
|
baseline and at 8 weeks (the end of intervention)
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Significant change (mean±SD) in serum concentration of hs-CRP
Time Frame: baseline and 8 weeks after intervention
|
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.
|
baseline and 8 weeks after intervention
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Significant change (mean±SD) in serum concentration of cytokine targets
Time Frame: baseline and 8 weeks after intervention
|
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.
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baseline and 8 weeks after intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shen-Ing Liu, PhD, Mackay Memorial Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Nutrition Disorders
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Depression
- Depressive Disorder
- Vitamin D Deficiency
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
Other Study ID Numbers
- 109-2314-B-195 -017 -MY3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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