Clinical trial NCT03766074: Vitamin D Supplementation in Patients With Depression
Official title: Evaluation of Vitamin D Supplementation Effects on Serum 25(OH)D3, PTH, Pro-inflammatory Biomarkers and Neurotransmitters Involved in Depression, and Depression Status in Depressive Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: vitamin D- Depression- Cholecalciferol-
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Groups (intervention group receives 50000 IU vitamin D and control group receives placebo) through a random allocation. After 8 weeks, blood sample will be collected from each participant. The studied indices (inflammatory (IL-1β, IL-6, hs-CRP), PTH, platelet serotonin, serum oxytocin, serum 25(OH) D, depression status and anthropometry indices) will be evaluated at beginning and end of interventional period.

Detailed description: In this double-blind randomized clinical trial, 60 patients aged 18-60y referred to Baharlou hospital with a history of mild to moderate depression diagnosed by a psychiatrist will be presented to the researcher. After receipt of a signed informed consent form, eligible patients will participate. A general demographic questionnaire will be completed by an interviewer. Individuals are randomly divided into intervention and control groups. A 10-ml venous blood sample will be collected from each participant. The intervention group receives 50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly. The control group receives placebo. The drug schedule of both groups (if any) will be unchanged according to the prescribing physician. After 8 weeks, blood sample will be collected from each participant. The studied indices (inflammatory (IL-1β, IL-6, hs-CRP), PTH, platelet serotonin, serum oxytocin, serum 25(OH) D, depression status, anthropometry indices) will be evaluated at beginning and end of interventional period. Data will be analyzed by statistical tests.

Eligibility criteria: Inclusion Criteria:

* age: 18 to 60 y
* Having mild to moderate depression

Exclusion Criteria:

* Having a history of heart infarction
* Having a history of angina
* Having a history of stroke
* Having a history of kidney stones
* Having a history of high blood pressure (systolic blood pressure higher than 174 or diastolic blood pressure higher than 104 mm Hg)
* Having a history of liver disease
* Having a history of hyperparathyroidism
* Pregnancy and/or lactation
* Reproductive-aged women (under 50 years old) who are not receiving adequate contraception
* Consuming nutritional supplement containing vitamin D from 2 months ago
* Not willing to continue the study
* Failure to follow the Supplemental Program

Primary outcomes:
measure: significant change (mean±SD) in vitamin D status
timeFrame: baseline and 8 weeks after intervention
Secondary outcomes:
measure: significant change (mean±SD) in serum concentration of IL-1β and IL-6.
timeFrame: baseline and 8 weeks after intervention
measure: significant change (mean±SD) in serum concentration of hs-CRP
timeFrame: baseline and 8 weeks after intervention
measure: significant change (mean±SD) in serum concentration of bone biomarker
timeFrame: baseline and 8 weeks after intervention
measure: significant change (mean±SD) in platelet serotonin concentration (ng/10^9 platelets)
timeFrame: baseline and 8 weeks after intervention
measure: significant change (mean±SD) in serum concentration of oxytocin (µU/mL)
timeFrame: baseline and 8 weeks after intervention
measure: significant change (mean±SD) in depression status
timeFrame: baseline and 8 weeks after intervention
Other outcomes:
Locations:
city: Tehrān
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
state: Tehran
Study officials:
affiliation: National Nutrition and Food Technology Research Institute
name: Tirang R. Neyestani, Ph.D
role: STUDY_CHAIR
References:
citation: Kaviani M, Nikooyeh B, Etesam F, Behnagh SJ, Kangarani HM, Arefi M, Yaghmaei P, Neyestani TR. Effects of vitamin D supplementation on depression and some selected pro-inflammatory biomarkers: a double-blind randomized clinical trial. BMC Psychiatry. 2022 Nov 11;22(1):694. doi: 10.1186/s12888-022-04305-3.