Effects of Vitamin D Supplementation on Depression and Inflammatory Markers

  • STATUS
    Recruiting
  • End date
    Jun 28, 2024
  • participants needed
    460
  • sponsor
    Mackay Memorial Hospital
Updated on 10 September 2021

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.

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-1710, 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.

Details
Condition major depressive disorder, major depressive disorders, Endogenous depression, Vitamin D Deficiency, Major depression, Vitamin Deficiency
Treatment Vitamin D3
Clinical Study IdentifierNCT04898725
SponsorMackay Memorial Hospital
Last Modified on10 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
Patients use drugs or herbals interfering with vitamin D metabolisms
phenobarbital
phenytoin
anti-tuberculosis drugs
thiazide diuretics
Pregnant or expect to be pregnant during study participation
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