Vitamin D Supplementation on Outcome and Disease Activity.

NCT04909931 | Completed DMC

• 1 other identifier: 64012
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rheumatoid Arthritis, Vitamin D , Disease Activity, DAS28ESR

Outcome Measures

Primary Outcomes (2)

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

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

  12 weeks

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

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

  12 weeks

Study Arms (2)

vitamin D supplementation group

EXPERIMENTAL

First arm ; add on vitamin D 40,000 IU/week for 12 weeks

Drug: Vitamin D 2

second arm

EXPERIMENTAL

add on placebo

Drug: Placebo

Interventions

Vitamin D 2 DRUG

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

vitamin D supplementation group

Placebo DRUG

Second arm : add on placebo for 12 weeks

second arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Department of Medical Services Ministry of Public Health of Thailand: lead

Study Sites (1)

Rajavithi hospital

Bangkok, Bangkok, Thailand

Location

Related Publications (3)

• 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.

  PMID: 29202486 BACKGROUND

• 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.

  PMID: 30729713 BACKGROUND

• 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.

  PMID: 31205940 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Ergocalciferols

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Sirilak Nunthiyakul, Medicine

  Department of Medical Services Ministry of Public Health of Thailand

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: June 2, 2021
• Study Start: May 1, 2021
• Primary Completion: May 15, 2022
• Study Completion: December 1, 2022
• Last Updated: January 7, 2025

Record last verified: 2022-02

Locations

TH (1)