ClinicalTrials.gg
CompletedNCT05260255Updated Jan 6, 2025

Effect of Vitamin D Supplement on Disease Activity in SLE

An interventional study of vitamin D2 ( calciferol ) and Placebo in Vitamin D Deficiency, Hypocalcemia and Hyperparathyroidism, sponsored by Department of Medical Services Ministry of Public Health of Thailand. Completed at 1 site in Thailand. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-06.

Sponsored by Department of Medical Services Ministry of Public Health of Thailand · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Vitamin D Deficiency
  • Hypocalcemia
  • Hyperparathyroidism
  • Systemic Lupus Erythematosus (Disorder)

Keywords

  • Hypocalcemia
  • Hyperparathyroidism
  • End Stage Renal Disease (ESRD)
  • calcitriol
  • Systemic Lupus Erythematosus ( SLE )
03

In context

Vitamin D Deficiency

801 studies on the registry are indexed under Vitamin D Deficiency; 60 are open to participants now.

This study's enrollment of 100 is above the median of 78 across 590 interventional studies indexed under Vitamin D Deficiency.

Browse Vitamin D Deficiency studies →

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand is the lead sponsor of 39 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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, \</= 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

Exclusion Criteria:

  • patients with chronic liver disease, CKD stage 3, bed ridden,
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    vitamin D supplementation

    add on vitamin D2 ( calciferol ) 40,000 IU/wk for 12 weeks

    Drug: vitamin D2 ( calciferol )

  • Placebo comparator
    placebo

    add on placebo for 12 weeks

    Drug: Placebo

Interventions

  • add on vitamin D2( calciferol ) 40,000 IU/wk ( 2 cap) for 12 weeks

  • DrugPlacebo

    add on placebo ( 2 cap ) for 12 weeks

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 weeks

Secondary outcomes

  1. To examine the effect of vitamin D supplementation on IL-6 level

    monitor serum vitamin D before and after intervention

    Time frame: 12 weeks

  2. 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 )

    Time frame: 12 weeks

  3. To determine adverse reaction of high dose vitamin D

    monitor adverse reaction of vitamin D after intervention

    Time frame: 12 weeks

  4. To study the effect of vitamin D supplementation on anti-dsDNA titer

    monitor serum anti-dsDNA titer before and after intervention

    Time frame: 12 weeks

07

Study locations

1 site
  • Rajavithi Hospital
    Bangkok, 10400, Thailand
08

References and documents

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 33084768 ↗
  • Hassanalilou 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 29280010 ↗
  • Aranow 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 ↗

Individual participant data

Plan to share: Yes

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05260255
Lead sponsor
Department of Medical Services Ministry of Public Health of Thailand
Responsible party
Sponsor
First posted
Mar 2, 2022
Start date
Jun 15, 2021
Primary completion
May 1, 2022
Completion
Dec 1, 2022
Last update
Jan 6, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ergocalciferols

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