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Vitamin D Supplementation in Patients With Depression

NCT ID: NCT03766074

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-06

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Depression

Keywords

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vitamin D- Depression- Cholecalciferol-

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

vitamin D supplement every other week

Group Type EXPERIMENTAL

vitamin D supplement

Intervention Type DIETARY_SUPPLEMENT

The intervention group receives 50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly.

control

Placebo every other week

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

placebo

Interventions

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vitamin D supplement

The intervention group receives 50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly.

Intervention Type DIETARY_SUPPLEMENT

Placebo

placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tirang R. Neyestani, Ph.D.

OTHER

Sponsor Role lead

Responsible Party

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Tirang R. Neyestani, Ph.D.

Tirang R. Neyestani, Ph.D. Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tirang R. Neyestani, Ph.D

Role: STUDY_CHAIR

National Nutrition and Food Technology Research Institute

Locations

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National Nutrition and Food Technology Research Institute

Tehrān, Tehran Province, Iran

Site Status

Countries

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Iran

References

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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.

Reference Type DERIVED
PMID: 36368945 (View on PubMed)

Other Identifiers

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784

Identifier Type: -

Identifier Source: org_study_id