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Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT01426347
Recruitment Status : Completed
First Posted : August 31, 2011
Results First Posted : March 20, 2017
Last Update Posted : March 20, 2017
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Rheumatoid Arthritis
Vitamin D Deficiency
Interventions Drug: Placebo sugar pill
Drug: Ergocalciferol
Enrollment 139
Recruitment Details  
Pre-assignment Details One hundred thirty-nine (139) participants were enrolled for visit 1, and blood was drawn to determine vitamin D levels. Eighty-three (83) were vitamin D deficient by criteria, vitamin D < 30 nanogram/milliliter (ng/ml), and entered the randomized controlled trial. The remaining 56 exited the study because they were vitamin D sufficient.
Arm/Group Title Placebo Group Ergocalciferol
Hide Arm/Group Description

Rheumatoid Arthritis (RA) patients with vitamin D deficiency will be randomized to placebo and active intervention arms.

Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.

Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.

Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.

Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks

Period Title: Overall Study
Started 41 42
Completed 34 39
Not Completed 7 3
Reason Not Completed
Lost to Follow-up             0             3
Protocol Violation             2             0
Withdrawal by Subject             5             0
Arm/Group Title Placebo Group Ergocalciferol Total
Hide Arm/Group Description

RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.

Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.

Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.

Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.

Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks

Total of all reporting groups
Overall Number of Baseline Participants 41 42 83
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 41 participants 42 participants 83 participants
52.7  (13.5) 52.2  (12.2) 52.5  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 83 participants
Female
33
  80.5%
36
  85.7%
69
  83.1%
Male
8
  19.5%
6
  14.3%
14
  16.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 participants 42 participants 83 participants
Caucasian 32 31 63
Non-caucasian 9 11 20
1.Primary Outcome
Title Disease Activity Score (DAS) 28
Hide Description

We measured disease activity as measured by DAS 28 at baseline and at the completion of Randomized Controlled trial, both in the placebo and the active treatment group.

We used DAS-28 scores to indicate disease activity. The DAS -28 scale has a minimum of 0 and a maximum of 10, with higher numbers indicating higher disease activity.

We used the following cut-offs: Remission (< 2.6), low disease activity (< 3.2), moderate disease activity (< 5.1) and high disease activity (> 5.1).

Time Frame Baseline and 16 weeks (end of Randomized Controlled Trial (RCT))
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Group Ergocalciferol
Hide Arm/Group Description:

RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.

Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.

Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.

Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.

Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks

Overall Number of Participants Analyzed 41 42
Mean (Standard Deviation)
Unit of Measure: composite score
Baseline 3.4  (1.5) 2.8  (1.3)
16 weeks (end of RCT) 3.5  (1.5) 3.1  (1.3)
2.Secondary Outcome
Title Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF)
Hide Description In each dimension and component of AIMS2-SF, item scores are from 0 to 10 with 10 being worst health.
Time Frame Baseline and 16 weeks (end of RCT)
Hide Outcome Measure Data
Hide Analysis Population Description
For placebo, analysis is based on 26 at baseline and 33 at the end of RCT For treatment, analysis is based on 27 at baseline and 38 at the end of RCT
Arm/Group Title Placebo Group Ergocalciferol
Hide Arm/Group Description:

RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.

Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.

Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.

Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.

Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks

Overall Number of Participants Analyzed 33 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 1.9  (1.3) 1.7  (1.6)
16 weeks (end of RCT) 1.9  (1.5) 1.6  (2.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Group Ergocalciferol
Hide Arm/Group Description

RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.

Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.

Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.

Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.

Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks

All-Cause Mortality
Placebo Group Ergocalciferol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Placebo Group Ergocalciferol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/42 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Group Ergocalciferol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/41 (0.00%)   0/42 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Uzma Jalal Haque
Organization: Johns Hopkins University
Phone: 410-550-0578
EMail: uhaque@jhmi.edu
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01426347    
Other Study ID Numbers: VDRA
First Submitted: August 29, 2011
First Posted: August 31, 2011
Results First Submitted: September 14, 2016
Results First Posted: March 20, 2017
Last Update Posted: March 20, 2017