NCT04898725Completed
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
Source: ClinicalTrials.gov · Last updated 9 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 142 (actual)
- First submitted
- 4 May 2021
- Start date
- 25 Dec 2020
- Primary completion date
- 2 Jul 2024
- Lead sponsor
- Mackay Memorial Hospital
- Diseases
- Depression
- NCT number
- NCT04898725
What you commit to
- Study type: Interventional
- Participants enrolled: 142
- From 25 Dec 2020 to the primary completion date, 2 Jul 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 9.Pregnant or expect to be pregnant during study participation.
Who the study is looking for
- 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.
Age in the registry: 10 years to 24 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MacKay Memorial Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.