Vitamin D Supplementation in Patients With Depression

Depression Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03766074
• Other study ID #: 784
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 6, 2018
• Est. completion date: September 2019

Study information

• Verified date: December 2018
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Dietary Supplement:
• vitamin D supplement
The intervention group receives 50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly.
• Placebo
placebo

Locations

Country	Name	City	State
Iran, Islamic Republic of	National Nutrition and Food Technology Research Institute	Tehran	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tirang R. Neyestani, Ph.D.

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	significant change (mean±SD) in vitamin D status	The serum concentration of 25(OH) D (nmol/L) will be measured at baseline and 8 weeks after intervention. normal range is 25-162 nmol/L	baseline and 8 weeks after intervention
Secondary	significant change (mean±SD) in serum concentration of IL-1ß and IL-6.	The serum concentration of IL-1ß and IL-6 (pg/mL) will be measured at baseline and 8 weeks after intervention.	baseline and 8 weeks after intervention
Secondary	significant change (mean±SD) in serum concentration of hs-CRP	The serum concentration of hs-CRP (mg/L) will be measured at baseline and 8 weeks after intervention. normal range is 0.3-8.6 mg/L.	baseline and 8 weeks after intervention
Secondary	significant change (mean±SD) in serum concentration of bone biomarker	The serum concentration of parathormone (PTH) (pg/mL) will be measured at baseline and 8 weeks after intervention. normal range is 10-65 pg/mL.	baseline and 8 weeks after intervention
Secondary	significant change (mean±SD) in platelet serotonin concentration (ng/10^9 platelets)	The platelet serotonin concentrations (ng/10^9 platelets) will be measured at baseline and 8 weeks after intervention. normal range is 154-1086.	baseline and 8 weeks after intervention
Secondary	significant change (mean±SD) in serum concentration of oxytocin (µU/mL)	The serum concentrations of oxytocin (µU/mL) will be measured at baseline and 8 weeks after intervention. normal range is : males:1.1-1.9, females (non-pregnant): 1.0-1.8	baseline and 8 weeks after intervention
Secondary	significant change (mean±SD) in depression status	Depression status will be measured by using Beck questioner at baseline and 8 weeks after intervention.	baseline and 8 weeks after intervention