Effects of Vitamin D Supplementation on Depression and Inflammatory Markers

NCT04898725 | Completed

• 1 other identifier: 109-2314-B-195 -017 -MY3
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depression; Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline and at 8 weeks (the end of intervention)

Secondary Outcomes (6)

• 17-item Hamilton Depression Rating Scale (HDRS-17)

  change from baseline score at 8 weeks

• Response rate of 17-item Hamilton Depression Rating Scale (HDRS-17)

  at 2 weeks, 4 weeks, 6 weeks, 8 weeks

• Remission rate of 17-item Hamilton Depression Rating Scale (HDRS-17)

  at week 2, 4, 6, 8 weeks

• End of intervention remission rate in17-item Hamilton Depression Rating Scale (HDRS-17)

  at 8 weeks

• Change of total score of Beck Depression Inventory-Second Edition

  change from baseline score at 8 weeks

Other Outcomes (3)

• Change of total score of Generalized Anxiety Disorder Questionnaire

  baseline and at 8 weeks (the end of intervention)

• Significant change (mean±SD) in serum concentration of hs-CRP

  baseline and 8 weeks after intervention

• Significant change (mean±SD) in serum concentration of cytokine targets

  baseline and 8 weeks after intervention

Study Arms (4)

Vit D Group (randomized)

EXPERIMENTAL

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

Dietary Supplement: Vitamin D3

Control Group (randomized)

NO INTERVENTION

Subjects will be randomly assigned to receive a placebo for 8 weeks.

Preference Vit D Group (non-randomized)

EXPERIMENTAL

Subjects with a strong preference to receive a daily vitamin D supplementation (4800IU daily) for 8 weeks.

Dietary Supplement: Vitamin D3

Preference no Vit D Group (non-randomized)

NO INTERVENTION

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

Interventions

Vitamin D3 DIETARY_SUPPLEMENT

Vitamin D3 4800IU daily

Preference Vit D Group (non-randomized); Vit D Group (randomized)

Eligibility Criteria

• Age: 10 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• patients who attend psychiatric outpatient clinics or who are admitted to the psychiatric inpatient ward at the above sites.
• clinical diagnosis of depression-related disorders and scores of HDRS-17 ≥ 10.
• psychotropics have been kept unchanged for at least a month.
• aged 10 to 24.
• serum 25-hydroxycholecalciferol (25-OH-D) levels lower than 20 ng/ml.

You may not qualify if:

• endocrine disorders
• including diabetes
• thyroid
• parathyroid disorder.
• serious neurological disorders
• epilepsy
• severe traumatic brain injury
• neurodegenerative conditions
• liver disease
• kidney disease
• heart disease
• other serious health conditions.
• severe mental disorders
• Organic mental disorders
• Alcohol or substance use disorders active within 3 months

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

MacKay Memorial Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Vitamin D Deficiency

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Shen-Ing Liu, PhD

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Attending Psychiatrist, Professor

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 24, 2021
• Study Start: December 25, 2020
• Primary Completion: July 2, 2024
• Study Completion: July 31, 2024
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)