Vitamin D Supplementation on Outcome and Disease Activity.

Overview

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

Full Title of Study: “Vitamin D Supplementation on Outcome and Disease Activity in Rheumatoid Arthritis Patients at Rajavithi Hospital : A Randomized Clinical Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 15, 2021

Interventions

  • Drug: Vitamin D 2
    • Randomized allocation first arm : add on vitamin D supplementation 40,000 iu/week for 12 weeks
  • Drug: Placebo
    • Second arm : add on placebo for 12 weeks

Arms, Groups and Cohorts

  • Experimental: vitamin D supplementation group
    • First arm ; add on vitamin D 40,000 IU/week for 12 weeks
  • Experimental: second arm
    • add on placebo

Clinical Trial Outcome Measures

Primary Measures

  • 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.
  • To study efficacy of vitamin D on IL-6 in RA patients at Rajavithi hospital
    • Time Frame: 12 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rajavithi Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Sirilak Nunthiyakul, Medicine, Study Chair, Rajavithi Hospital
  • Overall Contact(s)
    • Sirilak Nunthiyakul, Medicine, 0832973597, Dearly_medicine_143@hotmail.com

References

Polasik K, Piotrowska E, Lipinska B, Witkowski JM, Bryl E, Tukaj S. Vitamin D status in patients with rheumatoid arthritis: a correlation analysis with disease activity and progression, as well as serum IL-6 levels. Acta Biochim Pol. 2017;64(4):667-670. doi: 10.18388/abp.2017_1636. Epub 2017 Dec 5.

Gopal K, Thevarajah M, Ng CM, Raja J. Effects of vitamin D on disease activity and serum interleukin-6 in rheumatoid arthritis. Int J Rheum Dis. 2019 May;22(5):834-841. doi: 10.1111/1756-185X.13484. Epub 2019 Feb 6.

Aslam MM, John P, Bhatti A, Jahangir S, Kamboh MI. Vitamin D as a Principal Factor in Mediating Rheumatoid Arthritis-Derived Immune Response. Biomed Res Int. 2019 May 7;2019:3494937. doi: 10.1155/2019/3494937. eCollection 2019.

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