CompletedNot Applicable

Effect of Vitamin D Supplement on Disease Activity in SLE

Thailand100 participantsStarted 2021-06-15

Plain-language summary

To study the effect of vitamin D supplementation on disease activity of SLE ( SLEDAI-2K ) and IL-6 level

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 18 year-old * SLE classified by revised ACR criteria, SLICC 2012 criteria * SLE patients who have mild to moderate disease activity ( clinical SLEDAI-2K 3-10 ) and has vitamin D level \< 40 ng/ml * currently treated with stable dose of 1 or more of the following background medication : NSAIDs, anti-malarial, MMF, Azathioprine, methotrexate, cyclosporin for at least 1 month, corticosteroid \</= 20 mg/d of prednisolone or equivalent dose for at least 2 weeks * received calciferol 20,000 IU/wk (1 cap) at least 12 weeks Exclusion Criteria: * patients with chronic liver disease, CKD stage 3, bed ridden, malignancy * patients who received drug that interfere with vitamin D metabolism * poor drug compliance * overlap with other connective tissue disease or a diagnosis of MCTD * hx of vitamin D allergy * hx on MTV or other supplementation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To examine the effect of vitamin D supplementation on SLE disease activity

Timeframe: 12 weeks

Trial details

NCT IDNCT05260255

SponsorDepartment of Medical Services Ministry of Public Health of Thailand

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-05-01

View on ClinicalTrials.gov More Vitamin D Deficiency trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.