drugset / Trial / NCT03621553
Vitamin D Homeostasis in Sarcoidosis
RandomizedParallel-groupTriple-blindTreatment
Summary
This study evaluates the relationship between vitamin-D status and severity of sarcoidosis, and the effects of vitamin-D repletion in vitamin-D insufficient patients with sarcoidosis. Half the patients with sarcoidosis who are vitamin-D insufficient will receive standard vitamin-D supplementation via standard regimen while the other half will receive a placebo. Sarcoidosis patients who are vitamin-D sufficient will also act as controls.
Timeline
- Start
- 2010-07-01
- Primary completion
- 2026-02
- Completion
- 2026-12-30
Publications
- Results Capolongo G, Xu LH, Accardo M, Sanduzzi A, Stanziola AA, Colao A, Agostini C, Zacchia M, Capasso G, Adams-Huet B, Moe OW, Maalouf NM, Sakhaee K, Hsia CC. Vitamin-D status and mineral metabolism in two ethnic populations with sarcoidosis. J Investig Med. 2016 Jun;64(5):1025-34. doi: 10.1136/jim-2016-000101. Epub 2016 Apr 6.
- Results Vieth R. Why the optimal requirement for Vitamin D3 is probably much higher than what is officially recommended for adults. J Steroid Biochem Mol Biol. 2004 May;89-90(1-5):575-9. doi: 10.1016/j.jsbmb.2004.03.038.
- Results Bolland MJ, Wilsher ML, Grey A, Horne AM, Fenwick S, Gamble GD, Reid IR. Randomised controlled trial of vitamin D supplementation in sarcoidosis. BMJ Open. 2013 Oct 23;3(10):e003562. doi: 10.1136/bmjopen-2013-003562.
- Results Kamphuis LS, Bonte-Mineur F, van Laar JA, van Hagen PM, van Daele PL. Calcium and vitamin D in sarcoidosis: is supplementation safe? J Bone Miner Res. 2014 Nov;29(11):2498-503. doi: 10.1002/jbmr.2262.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ergocalciferol | Small molecule | 50000 iu | Oral |
| Background | Calcium Citrate with Vitamin D2 | Unknown | 200 mg | Oral |
| Background | Calcium Citrate with Vitamin D2 | Unknown | 250 iu | Oral |