Vitamin D Supplementation in Patients With Depression

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

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.

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: vitamin D supplement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran
    • Tehrān, Tehran, Iran, Islamic Republic of
      • National Nutrition and Food Technology Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; vitamin D supplement every other week	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_COMPARATOR: control; Placebo every other week	Dietary supplement: Placebo; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
significant change (mean±SD) in serum concentration of IL-1β and IL-6.	The serum concentration of IL-1β and IL-6 (pg/mL) will be measured at baseline and 8 weeks after intervention.	baseline and 8 weeks after intervention
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Tirang R. Neyestani, Ph.D.
• Investigators: Study Chair: Tirang R. Neyestani, Ph.D, National Nutrition and Food Technology Research Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 6, 2018
• Primary Completion (ANTICIPATED): April 1, 2019
• Study Completion (ANTICIPATED): September 1, 2019

Study Registration Dates

• First Submitted: December 4, 2018
• First Submitted That Met QC Criteria: December 4, 2018
• First Posted (ACTUAL): December 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 13, 2018
• Last Update Submitted That Met QC Criteria: December 11, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: vitamin D- Depression- Cholecalciferol-
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 784

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No