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OpenTrials
Completed

NCT Number: NCT01426347

Treatment of Vitamin D Deficiency in Patients With Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Avitaminosis Connective Tissue Diseases Deficiency Diseases Immune System Diseases Joint Diseases Malnutrition Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Rheumatic Diseases Skin and Connective Tissue Diseases Vitamin D Deficiency

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo sugar pill

Drug

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

Other names: Placebo

Ergocalciferol

Drug

Ergocalciferol 50,000 IU per week for 16 weeks

Other names: Vitamin D

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Vitamin Therapy in Rheumatoid Arthritis

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Aug 31, 2011
Registry last updated
Mar 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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