Status:
COMPLETED
Effects of Vitamin D Supplementation on Depression and Inflammatory Markers
Lead Sponsor:
Mackay Memorial Hospital
Conditions:
Major Depression
Vitamin D Deficiency
Eligibility:
All Genders
10-24 years
Phase:
NA
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 w...
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 D...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT04898725
Start Date
December 25 2020
End Date
July 31 2024
Last Update
August 9 2024
Active Locations (1)
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1
MacKay Memorial Hospital
Taipei, Taiwan