NCT05078502

Brief Summary

Several studies suggested low serum level of vitamin D have been associated with rheumatoid arthritis. So, the present study was designed to investigate the effect of vitamin D supplementation along with CsDMARD in patients with rheumatoid arthritis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 14, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

October 4, 2021

Last Update Submit

February 1, 2022

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

  • Severity of pain

    Changes in severity of pain will be measured through the Visual Analog Scale (VAS) at baseline and at 8 weeks, minimum value 0 and maximum value 10, higher score mean a worse outcome.

    8 weeks

  • Disease activity

    Changes in DAS-28-CRP score between placebo and intervention arm at baseline and after 8 weeks of treatment by DAS-28-CRP scale

    8 weeks

Secondary Outcomes (2)

  • measure serum 25 hydroxyvitamin D level

    8 weeks

  • C- Reactive Protein Level

    8 weeks

Study Arms (2)

Intervention Vitamin D3 along with CsDMARDs

ACTIVE COMPARATOR

One capsule of vitamin D3 (40000IU) weekly for 8 weeks

Dietary Supplement: Vitamin D3

Placebo of Vitamin D3 along with CsDMARDs

PLACEBO COMPARATOR

One capsule of placebo of vitamin D3(40000IU) weekly for 8 weeks

Dietary Supplement: Vitamin D3

Interventions

Vitamin D3DIETARY_SUPPLEMENT

One capsule of vitamin D3(40000IU) weekly for 8 weeks

Intervention Vitamin D3 along with CsDMARDsPlacebo of Vitamin D3 along with CsDMARDs

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who met 2010 ACR/EULAR criteria for Rheumatoid arthritis
  • Age: 18 years or above
  • Both gender

You may not qualify if:

  • Overlapped syndrome
  • Patients with renal and liver disease, malabsorption, hyperparathyroidism
  • Spondyloarthritis, psoriatic arthritis, Systemic lupus erythematosus
  • Patients receiving vitamin D3, anti TB like rifampicin, isoniazid, anti-seizure drugs within last two months
  • Patients unwilling to participate or unwilling to give written consent
  • Pregnant \& lactating woman
  • Impaired cognitive function

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BSMMU

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Prof. Md. Sayedur Rahman, MBBS, Mphil, FCPS

    BSMMU, Bangladesh

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Immediately after randomization, random numbers of the two sets were assigned as patient code number. One set was designated as intervention group and another set was placebo group. Then the set of code numbers that belong to the intervention group were written as patient ID numbers on the packages contained vitamin D3 capsules. On the other hand, the set belongs to the placebo group were designated as patient ID numbers on the packages containing placebo capsules. This total procedure was conducted by the persons unrelated to this research. Thus the participants, caregiver, outcome assessor and the analyst, who require being blind for such study, were effectively blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, double-blind, placebo controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Resident

Study Record Dates

First Submitted

October 4, 2021

First Posted

October 14, 2021

Study Start

June 1, 2021

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

February 16, 2022

Record last verified: 2022-02

Locations

BA(1)