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Completed

NCT Number: NCT05260255

Effect of Vitamin D Supplement on Disease Activity in SLE

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

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Key information

Conditions

Vitamin D Deficiency Autoimmune Diseases Avitaminosis Calcium Metabolism Disorders Chronic Disease Connective Tissue Diseases Deficiency Diseases Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Hypocalcemia Immune System Diseases Kidney Diseases Kidney Failure, Chronic Lupus Erythematosus, Systemic Male Urogenital Diseases Malnutrition Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Skin and Connective Tissue Diseases Systemic Lupus Erythematosus (Disorder) Urogenital Diseases Urologic Diseases Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rajavithi Hospital

Bangkok, 10400, Thailand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vitamin D2 ( calciferol )

Drug

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

Placebo

Drug

add on placebo ( 2 cap ) for 12 weeks

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 12 weeks

    monitor serum vitamin D before and after intervention

  2. To determine whether IL-6 can early detection in SLE disease flare

    Time frame: 12 weeks

    monitor serum IL-6 before and after intervention compare with SLE disease activity index ( SLEDAI-2K )

  3. To determine adverse reaction of high dose vitamin D

    Time frame: 12 weeks

    monitor adverse reaction of vitamin D after intervention

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

    Time frame: 12 weeks

    monitor serum anti-dsDNA titer before and after intervention

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study title

The Effect of Vitamin D Supplementation on Disease Activity of Systemic Lupus Erythematosus Patients: A Randomized Clinical Trial in Rajavithi Hospital

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 2, 2022
Registry last updated
Jan 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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