Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

• Sponsor: Johns Hopkins University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01426347
• Collaborator: (none)
• Enrollment: 139
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the effect of vitamin D repletion on disease activity and disability in patients with rheumatoid arthritis.

The investigators hypothesize that rheumatoid arthritis (RA) patients with vitamin D deficiency have greater disease activity and disability, compared to RA patients with normal vitamin D levels. The investigators also hypothesize that vitamin D treatment in these deficient patients will result in a decrease in RA disease activity and disability.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis; Vitamin D Deficiency	Drug: Placebo sugar pill; Drug: Ergocalciferol	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 139 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Vitamin Therapy in Rheumatoid Arthritis
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: placebo group 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.	Drug: Placebo sugar pill; Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.; Other Names: Placebo ; Drug: Ergocalciferol; Ergocalciferol 50,000 IU per week for 16 weeks; Other Names: Vitamin D
Active Comparator: Ergocalciferol 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.	Drug: Ergocalciferol; Ergocalciferol 50,000 IU per week for 16 weeks; Other Names: Vitamin D

Outcome Measures

Primary Outcome Measures

1. Disease Activity Score (DAS) 28 [Baseline and 16 weeks (end of Randomized Controlled Trial (RCT))]

   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).

Secondary Outcome Measures

1. Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF) [Baseline and 16 weeks (end of RCT)]

   In each dimension and component of AIMS2-SF, item scores are from 0 to 10 with 10 being worst health.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Rheumatoid Arthritis diagnosed according to American College of Rheumatology (ACR) criteria

• ages 18-75 years

Exclusion Criteria:

• Diagnosis of any other autoimmune disease:

such as Lupus, Scleroderma, Myositis, Sjogren's Syndrome, Vasculitis'

• Having any of the following conditions with in the last 6 months Hypercalcemia, Hyperparathyroidism, Active tuberculosis (TB), Lymphoma or any other type of cancer, Sarcoidosis, Seizure, Stroke

• Severe heart problems

• Kidney failure requiring dialysis treatment

• Liver failure or cirrhosis of the liver

• Poorly controlled hypertension

• current uncontrolled Depression, Bipolar Disorder, or other Psychiatric illness

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johns Hopkins University	Baltimore	Maryland	United States	21224

Sponsors and Collaborators

• Johns Hopkins University

Investigators

• Principal Investigator: Uzma J Haque, M.D., Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT01426347
• Other Study ID Numbers: VDRA
• First Posted: Aug 31, 2011
• Last Update Posted: Mar 20, 2017
• Last Verified: Jan 1, 2017

• Keywords provided by Johns Hopkins University: Rheumatoid Arthritis; Vitamin D deficiency; Disability
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Vitamin D Deficiency; Vitamin D; Ergocalciferols

Study Results

Participant Flow

Pre-assignment Detail	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

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 Participants	41	42	83
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.7 (13.5)	52.2 (12.2)	52.5 (12.8)
Sex: Female, Male (Count of Participants)
Female	33 80.5%	36 85.7%	69 83.1%
Male	8 19.5%	6 14.3%	14 16.9%
Race/Ethnicity, Customized (participants) [Number]
Caucasian	32 78%	31 73.8%	63 75.9%
Non-caucasian	9 22%	11 26.2%	20 24.1%

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
Measure Participants	41	42
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
Measure Participants	33	38
Baseline	1.9 (1.3)	1.7 (1.6)
16 weeks (end of RCT)	1.9 (1.5)	1.6 (2.1)

Adverse Events

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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo Group		Ergocalciferol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/42 (0%)
Other (Not Including Serious) Adverse Events
	Placebo Group		Ergocalciferol
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/42 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.