Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To study the effect of vitamin D supplementation on disease activity of SLE ( SLEDAI-2K ) and IL-6 level
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| vitamin D supplementation | Experimental | add on vitamin D2 ( calciferol ) 40,000 IU/wk for 12 weeks |
|
| placebo | Placebo Comparator | add on placebo for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vitamin D2 ( calciferol ) | Drug | add on vitamin D2( calciferol ) 40,000 IU/wk ( 2 cap) for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To examine the effect of vitamin D supplementation on IL-6 level | monitor serum vitamin D before and after intervention | 12 weeks |
| To determine whether IL-6 can early detection in SLE disease flare |
Not provided
Inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rajavithi Hospital | Bangkok | Bangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33084768 | Result | 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. | |
| 29280010 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| D006996 | Hypocalcemia |
| D006961 | Hyperparathyroidism |
| D008180 | Lupus Erythematosus, Systemic |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D004872 | Ergocalciferols |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | add on placebo ( 2 cap ) for 12 weeks |
|
monitor serum IL-6 before and after intervention compare with SLE disease activity index ( SLEDAI-2K )
| 12 weeks |
| To determine adverse reaction of high dose vitamin D | monitor adverse reaction of vitamin D after intervention | 12 weeks |
| To study the effect of vitamin D supplementation on anti-dsDNA titer | monitor serum anti-dsDNA titer before and after intervention | 12 weeks |
| 25777546 | Result | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |