Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis - Full Text View

Purpose

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	Intervention
Rheumatoid Arthritis Vitamin D Deficiency	Drug: Placebo sugar pill Drug: Ergocalciferol


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Vitamin Therapy in Rheumatoid Arthritis

Resource links provided by NLM:

Genetics Home Reference related topics: rheumatoid arthritis

MedlinePlus related topics: Arthritis Rheumatoid Arthritis Vitamin D Vitamin D Deficiency

Drug Information available for: Ergocalciferol Vitamin D

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

Disease Activity Score (DAS) 28 [ Time Frame: 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:

Physical Function as Measured by Arthritis Impact Measurement Scales - Short Form (AIMS2 - SF) [ Time Frame: 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.


Enrollment:	139
Study Start Date:	January 2009
Study Completion Date:	January 2012
Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: Placebo Drug: Ergocalciferol Ergocalciferol 50,000 IU per week for 16 weeks Other Name: 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 Name: Vitamin D

Eligibility


Ages Eligible for Study:	18 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01426347

Locations


United States, Maryland
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

More Information


Responsible Party:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT01426347 History of Changes
Other Study ID Numbers:	VDRA
Study First Received:	August 29, 2011
Results First Received:	September 14, 2016
Last Updated:	January 27, 2017

Keywords provided by Johns Hopkins University:


Rheumatoid Arthritis Vitamin D deficiency Disability

Additional relevant MeSH terms:


Arthritis Arthritis, Rheumatoid Vitamin D Deficiency Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Avitaminosis	Deficiency Diseases Malnutrition Nutrition Disorders Vitamins Vitamin D Ergocalciferols Micronutrients Growth Substances Physiological Effects of Drugs Bone Density Conservation Agents

ClinicalTrials.gov processed this record on September 21, 2017