NCT03766074

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

December 13, 2018

Status Verified

December 1, 2018

Enrollment Period

11 months

First QC Date

December 4, 2018

Last Update Submit

December 11, 2018

Conditions

Depression

Keywords

vitamin D- Depression- Cholecalciferol-

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • significant change (mean±SD) in serum concentration of IL-1β and IL-6.

    baseline and 8 weeks after intervention

  • significant change (mean±SD) in serum concentration of hs-CRP

    baseline and 8 weeks after intervention

  • significant change (mean±SD) in serum concentration of bone biomarker

    baseline and 8 weeks after intervention

  • significant change (mean±SD) in platelet serotonin concentration (ng/10^9 platelets)

    baseline and 8 weeks after intervention

  • significant change (mean±SD) in serum concentration of oxytocin (µU/mL)

    baseline and 8 weeks after intervention

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

vitamin D supplement every other week

Dietary Supplement: vitamin D supplement

control

PLACEBO COMPARATOR

Placebo every other week

Dietary Supplement: Placebo

Interventions

vitamin D supplementDIETARY_SUPPLEMENT

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

Intervention
PlaceboDIETARY_SUPPLEMENT

placebo

control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Nutrition and Food Technology Research Institute

Tehrān, Tehran Province, Iran

Location

Related Publications (1)

  • 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.

    PMID: 36368945DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Tirang R. Neyestani, Ph.D

    National Nutrition and Food Technology Research Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Tirang R. Neyestani, Ph.D. Professor

Study Record Dates

First Submitted

December 4, 2018

First Posted

December 5, 2018

Study Start

May 6, 2018

Primary Completion

April 1, 2019

Study Completion

September 1, 2019

Last Updated

December 13, 2018

Record last verified: 2018-12

Locations

IR(1)