Vitamin D DeficiencyNCT05260255
Effect of Vitamin D Supplement on Disease Activity in SLE
A study testing vitamin D2 ( calciferol ) in people with Vitamin D Deficiency and Hypocalcemia, run by Department of Medical Services Ministry of Public Health of Thailand at 1 site in Thailand.
Trial summary
To study the effect of vitamin D supplementation on disease activity of SLE ( SLEDAI-2K ) and IL-6 level Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Hypocalcemia, Hyperparathyroidism
- What is being tested?
- vitamin D2 ( calciferol )
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- 15 Jun 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 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Vitamin D Supplementation on Disease Activity of Systemic Lupus Erythematosus Patients: A Randomized Clinical Trial in Rajavithi Hospital
To study the effect of vitamin D supplementation on disease activity of SLE ( SLEDAI-2K ) and IL-6 level
- Conditions
- Vitamin D Deficiency, Hypocalcemia, Hyperparathyroidism, Systemic Lupus Erythematosus (Disorder)
- Being tested
- vitamin D2 ( calciferol ), Placebo
- Keywords
- Hypocalcemia, Hyperparathyroidism, End Stage Renal Disease (ESRD), calcitriol, Systemic Lupus Erythematosus ( SLE )
- Medical subject headings
- Vitamin D Deficiency, Hypocalcemia, Hyperparathyroidism, Lupus Erythematosus, Systemic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D2 ( calciferol )Drug
add on vitamin D2( calciferol ) 40,000 IU/wk ( 2 cap) for 12 weeks
PlaceboDrug
add on placebo ( 2 cap ) for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| vitamin D supplementation | Experimental | add on vitamin D2 ( calciferol ) 40,000 IU/wk for 12 weeks Receives: Drug: vitamin D2 ( calciferol ) |
| placebo | Placebo comparator | add on placebo for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To examine the effect of vitamin D supplementation on SLE disease activity
Study the SLE disease activity by SLEDAI-2K in relation with vitamin D levels
Measured: 12 weeks
Secondary outcomes (4)
To examine the effect of vitamin D supplementation on IL-6 level
monitor serum vitamin D before and after intervention
Measured: 12 weeks
To determine whether IL-6 can early detection in SLE disease flare
monitor serum IL-6 before and after intervention compare with SLE disease activity index ( SLEDAI-2K )
Measured: 12 weeks
To determine adverse reaction of high dose vitamin D
monitor adverse reaction of vitamin D after intervention
Measured: 12 weeks
To study the effect of vitamin D supplementation on anti-dsDNA titer
monitor serum anti-dsDNA titer before and after intervention
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 Mar 2022
- Study start15 Jun 2021
- Primary completion1 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 Vitamin D DeficiencyStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Medical Services Ministry of Public Health of Thailand
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05260255
- Sponsor's protocol ID
- 64013
- Status last verified
- May 2021
- First submitted
- 12 May 2021
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Ding J, Su S, You T, Xia T, Lin X, Chen Z, Zhang L. Serum interleukin-6 level is correlated with the disease activity of systemic lupus erythematosus: a meta-analysis. Clinics (Sao Paulo). 2020 Oct 19;75:e1801. doi: 10.6061/clinics/2020/e1801. eCollection 2020.
PubMed 33084768Hassanalilou T, Khalili L, Ghavamzadeh S, Shokri A, Payahoo L, Bishak YK. Role of vitamin D deficiency in systemic lupus erythematosus incidence and aggravation. Auto Immun Highlights. 2017 Dec 26;9(1):1. doi: 10.1007/s13317-017-0101-x.
PubMed 29280010Aranow C, Kamen DL, Dall'Era M, Massarotti EM, Mackay MC, Koumpouras F, Coca A, Chatham WW, Clowse ME, Criscione-Schreiber LG, Callahan S, Goldmuntz EA, Keyes-Elstein L, Oswald M, Gregersen PK, Diamond B. Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Vitamin D3 on the Interferon Signature in Patients With Systemic Lupus Erythematosus. Arthritis Rheumatol. 2015 Jul;67(7):1848-57. doi: 10.1002/art.39108.
PubMed 25777546
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vitamin D Supplementation on Disease Activity of Systemic Lupus Erythematosus Patients: A Randomized Clinical Trial in Rajavithi Hospital
- ClinicalTrials.gov ID
- NCT05260255
- Acronym / sponsor ID
- 64013
- Conditions
- Vitamin D Deficiency, Hypocalcemia, Hyperparathyroidism, Systemic Lupus Erythematosus (Disorder)
- Keywords
- Hypocalcemia, Hyperparathyroidism, End Stage Renal Disease (ESRD), calcitriol, Systemic Lupus Erythematosus ( SLE )
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Department of Medical Services Ministry of Public Health of ThailandOther government
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 2 Mar 2022 (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 the effect of vitamin D supplementation on disease activity of SLE ( SLEDAI-2K ) and IL-6 level
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin D supplementation | Experimental | Drug: vitamin D2 ( calciferol )add on vitamin D2 ( calciferol ) 40,000 IU/wk for 12 weeks |
| placebo | Placebo comparator | Drug: Placeboadd on placebo for 12 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 D2 ( calciferol )add on vitamin D2( calciferol ) 40,000 IU/wk ( 2 cap) for 12 weeks | Drug | vitamin D supplementation |
| Placeboadd on placebo ( 2 cap ) for 12 weeks | Drug | placebo |
Primary outcome
To examine the effect of vitamin D supplementation on SLE disease activity
Time frame: 12 weeks
Study the SLE disease activity by SLEDAI-2K in relation with vitamin D levels
4 secondary outcomes
To examine the effect of vitamin D supplementation on IL-6 level
Time frame: 12 weeks
To determine whether IL-6 can early detection in SLE disease flare
Time frame: 12 weeks
To determine adverse reaction of high dose vitamin D
Time frame: 12 weeks
To study the effect of vitamin D supplementation on anti-dsDNA titer
Time frame: 12 weeks
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 6 Jan 2025.
- Results publication: PubMed 33084768Ding J, Su S, You T, Xia T, Lin X, Chen Z, Zhang L. Serum interleukin-6 level is correlated with the disease activity of systemic lupus erythematosus: a meta-analysis. Clinics (Sao Paulo). 2020 Oct 19;75:e1801. doi: 10.6061/clinics/2020/e1801. eCollection 2020.
- Results publication: PubMed 29280010Hassanalilou T, Khalili L, Ghavamzadeh S, Shokri A, Payahoo L, Bishak YK. Role of vitamin D deficiency in systemic lupus erythematosus incidence and aggravation. Auto Immun Highlights. 2017 Dec 26;9(1):1. doi: 10.1007/s13317-017-0101-x.
- Results publication: PubMed 25777546Aranow C, Kamen DL, Dall'Era M, Massarotti EM, Mackay MC, Koumpouras F, Coca A, Chatham WW, Clowse ME, Criscione-Schreiber LG, Callahan S, Goldmuntz EA, Keyes-Elstein L, Oswald M, Gregersen PK, Diamond B. Randomized, Double-Blind, Placebo-Controlled Trial of the Effect of Vitamin D3 on the Interferon Signature in Patients With Systemic Lupus Erythematosus. Arthritis Rheumatol. 2015 Jul;67(7):1848-57. doi: 10.1002/art.39108.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 D2 ( calciferol ) in people with Vitamin D Deficiency and Hypocalcemia, 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 5 inclusion and 6 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 6 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. Some participants in this study may receive a placebo. 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 examine the effect of vitamin D supplementation on SLE disease activity (time frame: 12 weeks). 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 NCT05260255, 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 6 Jan 2025.