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Effects of Vitamin D Supplementation on Depression and Inflammatory Markers

Primary Purpose

Major Depression, Vitamin D Deficiency

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Vitamin D3
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Major Depression

Eligibility Criteria

10 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    1. including diabetes
    2. thyroid
    3. parathyroid disorder.
  • 2.serious neurological disorders

    1. epilepsy
    2. severe traumatic brain injury
    3. neurodegenerative conditions
  • 3.liver disease
  • 4.kidney disease
  • 5.heart disease
  • 6.other serious health conditions.
  • 7.severe mental disorders

    1. Organic mental disorders
    2. Alcohol or substance use disorders active within 3 months
    3. Schizophrenia
    4. Delusional disorder
    5. Psychotic disorders not elsewhere classified.
    6. Bipolar disorder.
    7. Autistic spectrum disorder.
    8. Anorexia nervosa.
    9. Mental retardation with IQ less than 70.
    10. High violence or suicide risk.
  • 8.Patients use drugs or herbals interfering with vitamin D metabolisms

    1. phenobarbital
    2. phenytoin
    3. anti-tuberculosis drugs
    4. thiazide diuretics.
  • 9.Pregnant or expect to be pregnant during study participation.

Sites / Locations

  • MacKay Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

Vit D Group (randomized)

Control Group (randomized)

Preference Vit D Group (non-randomized)

Preference no Vit D Group (non-randomized)

Arm Description

Subjects will be randomly assigned to receive a daily vitamin D supplementation (4800IU daily) for 8 weeks

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.

Subjects with a strong preference to receive usual care (not receiving vitamin D supplements) for 8 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.
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).
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.
Significant change (mean±SD) in vitamin D status
serum levels of 25(OH)D, units of measure is ng/mL

Full Information

First Posted
May 4, 2021
Last Updated
July 12, 2023
Sponsor
Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04898725
Brief Title
Effects of Vitamin D Supplementation on Depression and Inflammatory Markers
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 12, 2021 (Actual)
Primary Completion Date
April 28, 2024 (Anticipated)
Study Completion Date
June 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression, Vitamin D Deficiency

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
460 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vit D Group (randomized)
Arm Type
Experimental
Arm Description
Subjects will be randomly assigned to receive a daily vitamin D supplementation (4800IU daily) for 8 weeks
Arm Title
Control Group (randomized)
Arm Type
No Intervention
Arm Description
Subjects will be randomly assigned to receive a placebo for 8 weeks.
Arm Title
Preference Vit D Group (non-randomized)
Arm Type
Experimental
Arm Description
Subjects with a strong preference to receive a daily vitamin D supplementation (4800IU daily) for 8 weeks.
Arm Title
Preference no Vit D Group (non-randomized)
Arm Type
No Intervention
Arm Description
Subjects with a strong preference to receive usual care (not receiving vitamin D supplements) for 8 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D3
Intervention Description
Vitamin D3 4800IU daily
Primary Outcome Measure Information:
Title
Change of total score of 17-item Hamilton Depression Rating Scale (HDRS-17)
Description
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)
Secondary Outcome Measure Information:
Title
17-item Hamilton Depression Rating Scale (HDRS-17)
Description
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
Title
Response rate of 17-item Hamilton Depression Rating Scale (HDRS-17)
Description
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
Title
Remission rate of 17-item Hamilton Depression Rating Scale (HDRS-17)
Description
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
Title
End of intervention remission rate in17-item Hamilton Depression Rating Scale (HDRS-17)
Description
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
Title
Change of total score of Beck Depression Inventory-Second Edition
Description
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
Title
Significant change (mean±SD) in vitamin D status
Description
serum levels of 25(OH)D, units of measure is ng/mL
Time Frame
baseline and at 8 weeks
Other Pre-specified Outcome Measures:
Title
Change of total score of Generalized Anxiety Disorder Questionnaire
Description
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)
Title
Significant change (mean±SD) in serum concentration of hs-CRP
Description
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
Title
Significant change (mean±SD) in serum concentration of cytokine targets
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Chun Huang, PhD
Phone
+886-2-28094661
Ext
3055
Email
aihch@mmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shen-Ing Liu, PhD
Organizational Affiliation
Mackay Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
MacKay Memorial Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-Chun Huang, PhD
Phone
+886-2-28094661
Ext
3055
Email
aihch@mmh.org.tw

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Vitamin D Supplementation on Depression and Inflammatory Markers

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