Vitamin D Supplementation in Patients With Depression

Tirang R. Neyestani, Ph.D.

Status

Unknown

Conditions

Depression

Treatments

Dietary Supplement: Placebo

Dietary Supplement: vitamin D supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT03766074

784

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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