Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

• 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: Johns Hopkins University
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Placebo Group	Ergocalciferol	Total
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
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

Outcome Measures

1. Primary Outcome

Title	Disease Activity Score (DAS) 28
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))

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Placebo Group	Ergocalciferol
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)
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)

Outcome Measure Data

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
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)

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Placebo Group	Ergocalciferol
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	--/--	--/--
Serious Adverse Events
	Placebo Group	Ergocalciferol
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/41 (0.00%)	0/42 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Uzma Jalal Haque
• Organization: Johns Hopkins University
• Phone: 410-550-0578
• EMail: uhaque@jhmi.edu

• 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