NCT03754712

Brief Summary

Several studies suggested low serum levels of vitamin D have been associated with depression. So, the present study is designed to investigate the effect of vitamin D administration along with SSRIs in patients with MDD.

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
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 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

March 10, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

November 28, 2018

Status Verified

November 1, 2018

Enrollment Period

10 months

First QC Date

November 25, 2018

Last Update Submit

November 27, 2018

Conditions

MDD

Outcome Measures

Primary Outcomes (1)

  • Severity of depression

    Changes in severity of depression will be measured through the Patient Health Questionnaire - 9 (PHQ - 9) score at baseline and at 8 weeks

    8 weeks

Study Arms (2)

Intervention Vitamin D3 along with SSRIs

ACTIVE COMPARATOR

One tablet of vitamin D3 (2000IU) per day for 8 weeks

Dietary Supplement: Vitamin D3

SSRIs

NO INTERVENTION

Patients treated with SSRIs

Interventions

Vitamin D3DIETARY_SUPPLEMENT

Dietary supplement : Vitamin D3 one tablet of vitamin D3 (2000IU) per day for 8 weeks

Intervention Vitamin D3 along with SSRIs

Eligibility Criteria

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

You may qualify if:

  • patients with MDD
  • patients with PHQ - 9 score more than 10
  • serum vitamin D less than 30 ng/ml
  • Serum calcium level 8.5-10.5 mg/dl

You may not qualify if:

  • Patients receiving antidepressant and dietary supplement with in last two months.
  • Patients with other psychological disorder ( such as schizophrenia, bipolar affective disorder)
  • Patients with parathyroid disease, thyroid disease, liver and kidney disease
  • Patients with Diabetes mellitus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BSMMU

Dhaka, Bangladesh

RECRUITING

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Central Study Contacts

Tanzina Afrin, MBBS

CONTACT

01796372338Tanzina.afrin800@gmail.com

Sultanul Arifin, MBBS

CONTACT

01723836535Sam35th@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Resident

Study Record Dates

First Submitted

November 25, 2018

First Posted

November 27, 2018

Study Start

March 10, 2018

Primary Completion

January 10, 2019

Study Completion

February 28, 2019

Last Updated

November 28, 2018

Record last verified: 2018-11

Locations

BA(1)