Rheumatoid Arthritis, Vitamin D , Disease Activity, DAS28ESRNCT04909931
Vitamin D Supplementation on Outcome and Disease Activity.
A study testing Vitamin D 2 in people with Rheumatoid Arthritis, Vitamin D , Disease Activity, DAS28ESR, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
To study efficacy of Vitamin D on outcome and disease activity ; DAS28-ESR in Rheumatoid arthritis patients at Rajavithi hospital . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Vitamin D , Disease Activity, DAS28ESR
- What is being tested?
- Vitamin D 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Vitamin D allergy
- received other drugs which have vitamin D component
- serum Vitamin D less than 10 ng/mL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D Supplementation on Outcome and Disease Activity in Rheumatoid Arthritis Patients At Rajavithi Hospital : a Randomized Clinical Trial
To study efficacy of Vitamin D on outcome and disease activity ; DAS28-ESR in Rheumatoid arthritis patients at Rajavithi hospital .
- Being tested
- Vitamin D 2, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D 2Drug
Randomized allocation first arm : add on vitamin D supplementation 40,000 iu/week for 12 weeks
PlaceboDrug
Second arm : add on placebo for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| vitamin D supplementation group | Experimental | First arm ; add on vitamin D 40,000 IU/week for 12 weeks Receives: Drug: Vitamin D 2 |
| second arm | Experimental | add on placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start1 May 2021
- Primary completion15 May 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis, Vitamin D , Disease Activity, DAS28ESRStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sirilak Nunthiyakul, Medicine, Study chair, Department of Medical Services Ministry of Public Health of Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909931
- Sponsor's protocol ID
- 64012
- Status last verified
- Feb 2022
- First submitted
- 11 May 2021
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29202486Gopal 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.
PubMed 30729713Aslam 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.
PubMed 31205940
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation on Outcome and Disease Activity in Rheumatoid Arthritis Patients At Rajavithi Hospital : a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04909931
- Acronym / sponsor ID
- 64012
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 1 May 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study efficacy of Vitamin D on outcome and disease activity ; DAS28-ESR in Rheumatoid arthritis patients at Rajavithi hospital .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D supplementation group | Experimental | Drug: Vitamin D 2First arm ; add on vitamin D 40,000 IU/week for 12 weeks |
| second arm | Experimental | Drug: Placeboadd on placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin D 2Randomized allocation first arm : add on vitamin D supplementation 40,000 iu/week for 12 weeks | Drug | vitamin D supplementation group |
| PlaceboSecond arm : add on placebo for 12 weeks | Drug | second arm |
Primary outcome
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
DAS-28 ESR measure from swollen joint count, tender joint count, ESR and patient global assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Background: PubMed 29202486Polasik 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.
- Background: PubMed 30729713Gopal 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.
- Background: PubMed 31205940Aslam 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sirilak Nunthiyakul, Medicine study chair
Department of Medical Services Ministry of Public Health of Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D 2 in people with Rheumatoid Arthritis, Vitamin D , Disease Activity, DAS28ESR, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study efficacy of vitamin D on disease activity RA patients at Rajavithi hospital (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04909931, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.