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Vitamin D Supplementation on Outcome and Disease Activity.

Primary Purpose

Rheumatoid Arthritis, Vitamin D , Disease Activity, DAS28ESR

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Vitamin D 2
Placebo
Sponsored by
Rajavithi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis, Vitamin D , Disease Activity, DAS28ESR

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rajavithi hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

vitamin D supplementation group

second arm

Arm Description

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

add on placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 11, 2021
Last Updated
May 31, 2021
Sponsor
Rajavithi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04909931
Brief Title
Vitamin D Supplementation on Outcome and Disease Activity.
Official Title
Vitamin D Supplementation on Outcome and Disease Activity in Rheumatoid Arthritis Patients at Rajavithi Hospital : A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2021 (Anticipated)
Primary Completion Date
December 15, 2021 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rajavithi Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Vitamin D , Disease Activity, DAS28ESR

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
vitamin D supplementation group
Arm Type
Experimental
Arm Description
First arm ; add on vitamin D 40,000 IU/week for 12 weeks
Arm Title
second arm
Arm Type
Experimental
Arm Description
add on placebo
Intervention Type
Drug
Intervention Name(s)
Vitamin D 2
Intervention Description
Randomized allocation first arm : add on vitamin D supplementation 40,000 iu/week for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Second arm : add on placebo for 12 weeks
Primary Outcome Measure Information:
Title
To study efficacy of vitamin D on disease activity RA patients at Rajavithi hospital
Description
Determine disease activity by DAS28-ESR in relation with vitamin D supplementation.
Time Frame
12 weeks
Title
To study efficacy of vitamin D on IL-6 in RA patients at Rajavithi hospital
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sirilak Nunthiyakul, Medicine
Phone
0832973597
Email
Dearly_medicine_143@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kittiwan Sumethkul, Rheumato
Phone
0896658160
Email
ckittiwan@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sirilak Nunthiyakul, Medicine
Organizational Affiliation
Rajavithi Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Rajavithi hospital
City
Bangkok
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sirilak Nunthiyakul, Medicine
Phone
0832973597
Email
Dearly_medicine_143@hotmail.com
First Name & Middle Initial & Last Name & Degree
Kittiwan Sumethkul, rheumato
Phone
0896658160
Email
ckittiwan@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29202486
Citation
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.
Results Reference
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PubMed Identifier
30729713
Citation
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.
Results Reference
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PubMed Identifier
31205940
Citation
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.
Results Reference
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Vitamin D Supplementation on Outcome and Disease Activity.

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