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Completed

NCT Number: NCT04909931

Vitamin D Supplementation on Outcome and Disease Activity.

To study efficacy of Vitamin D on outcome and disease activity ; DAS28-ESR in Rheumatoid arthritis patients at Rajavithi hospital .

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Key information

Conditions

Rheumatoid Arthritis, Vitamin D , Disease Activity, DAS28ESR Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rajavithi hospital

Bangkok, Thailand

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age > 18 yrs old
  • RA diagnosed by ACR/EULAR 2010
  • low to moderate disease activity
  • on stable NSAIDs and DMARDs for at least 1 month
  • Received Prednisolone less than or equal to 7.5 mg/day
  • serum calcium, phosphorus and ALP are within normal limit.

Exclusion criteria

  • Chronic kidney disease stage 3 or higher
  • History of TB
  • History of Chronic liver disease
  • Pregnancy or breast-feeding
  • adjustment of immuno-suppressive drugs, steroid
  • other connective tissue disease
  • Vitamin D allergy
  • received other drugs which have vitamin D component
  • serum Vitamin D less than 10 ng/mL

Treatment and study plan

Vitamin D 2

Drug

Randomized allocation first arm : add on vitamin D supplementation 40,000 iu/week for 12 weeks

Placebo

Drug

Second arm : add on placebo for 12 weeks

Primary outcomes

  1. To study efficacy of vitamin D on disease activity RA patients at Rajavithi hospital

    Time frame: 12 weeks

    Determine disease activity by DAS28-ESR in relation with vitamin D supplementation.

  2. To study efficacy of vitamin D on IL-6 in RA patients at Rajavithi hospital

    Time frame: 12 weeks

    DAS-28 ESR measure from swollen joint count, tender joint count, ESR and patient global assessment

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study title

Vitamin D Supplementation on Outcome and Disease Activity in Rheumatoid Arthritis Patients At Rajavithi Hospital : a Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 2, 2021
Registry last updated
Jan 7, 2025

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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