Vitamin D Homeostasis in Sarcoidosis

Sarcoidosis Clinical Trial

Official title:

Vitamin D Homeostasis in Sarcoidosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03621553
• Other study ID #: STU 062010-055
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 1, 2010
• Est. completion date: December 30, 2026

Study information

• Verified date: November 2023
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Sarcoidosis is a multi-system inflammatory disease characterized by T-helper lymphocyte hyperactivity leading to granulomatous inflammation. The granuloma cells autonomously convert 25-hydroxy-vitamin-D (25OHD) to the active metabolite 1,25-dihydroxy-vitamin-D (1,25OH2D) independent of normal feedback control but dependent on substrate (25OHD) concentration. Circulating 1,25OH2D exerts both anti-inflammatory and mineral metabolic actions. Deficiency of 25OHD limits substrate-dependent 1,25OH2D synthesis, diminishes anti-antigenic innate immunity and augments pro-inflammatory adaptive immunity. Thus, low vitamin-D stores could aggravate sarcoid inflammation while repletion of vitamin-D stores could mitigate inflammation in sarcoidosis.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: December 30, 2026
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Stable medical condition defined as no hospitalization or emergency room visit in the previous 3 months
• No evidence of active pulmonary or systemic infection
• No other active inflammatory disease,
• No active malignancy.
• Normal serum ionized calcium level

Exclusion Criteria:

• Hospitalization or emergency room visit in the previous 3 months
• Evidence of active pulmonary or systemic infection
• Evidence of active other inflammatory disease
• Evidence of active malignancy
• Elevated serum ionized calcium level

Related Conditions & MeSH terms

• Sarcoidosis
• Vitamin D Insufficiency

Intervention

Drug:
• Ergocalciferol
Vitamin D2 50,000 units
• Placebo
Sugar pill manufactured to mimic ergocalciferol 50,000 units
• Calcium Citrate with Vitamin D2
To meet the recommended minimum daily dietary requirements

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center, and Parkland Health and Hospital System	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. 2 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in lung function from baseline	(Measurement at end of study)/(measurement at enrollment)	Baseline and 24 weeks
Secondary	Change in King's Sarcoidosis Questionnaire Score	Standard validated questionnaire for assessing the impact of sarcoidosis on quality of life. Questions address symptoms, activities and psychosocial impacts of disease. It consists of 29 questions on general health, medications, and symptoms in lung, skin, and eyes, summed to derive a total score. Each question is scored on a scale of 1 (worst) to 7 (best). Minimum total score = 5 (poorest health). Maximum total score = 203 (best health).	Baseline, 12 and 24 weeks
Secondary	Change in six minute walk distance	(Measurement at end of study)/(measurement at enrollment)	Baseline and 24 weeks
Secondary	Change in blood cell counts from complete blood count (CBC)	(Measurement at study point)/(initial measurement at enrollment)	Baseline, 12 and 24 weeks
Secondary	Change in metabolic profile from complete metabolic panel (CMP)	(Measurement at study point)/(initial measurement at enrollment)	Baseline, 12 and 24 weeks
Secondary	Change in serum vitamin-D metabolite concentration	(Measurement at study point)/(initial measurement at enrollment)	Baseline, 12 and 24 weeks
Secondary	Change in serum angiotensin converting enzyme (ACE) concentration	(Measurement at study point)/(initial measurement at enrollment)	Baseline, 12 and 24 weeks
Secondary	Change in serum serum gamma-globulin concentration	(Measurement at study point)/(initial measurement at enrollment)	Baseline, 12 and 24 weeks
Secondary	Change in serum C-reactive protein (CRP) concentration	(Measurement at study point)/(initial measurement at enrollment)	Baseline, 12 and 24 weeks
Secondary	Change in serum tumor Necrosis factor-alpha (TNF-alpha) concentration	(Measurement at study point)/(initial measurement at enrollment)	Baseline, 12 and 24 weeks
Secondary	Change in serum interferon-gamma (IFN-gamma) concentration	(Measurement at study point)/(initial measurement at enrollment)	Baseline, 12 and 24 weeks
Secondary	Changes in serum interleukin concentration	(Measurement at study point)/(initial measurement at enrollment)	Baseline, 12 and 24 weeks
Secondary	Change in 24 hour urine calcium/creatinine ratio	(Measurement at study point)/(initial measurement at enrollment)	Baseline, 12 and 24 weeks
Secondary	Change in 24 hour urine deoxypyridinoline concentration	(Measurement at study point)/(initial measurement at enrollment)	Baseline, 12 and 24 weeks
Secondary	Change in fractional lung tissue volume on computed/positron emission tomography (PET/CT)	(Measurement at end of study)/(measurement at enrollment)	Baseline and 24 weeks
Secondary	Change in Fluoro-deoxyglucose (FDG) uptake on PET/CT	(Measurement at end of study)/(measurement at enrollment	Baseline and 24 weeks
Secondary	Change in bone density z-score	(Measurement at end of study)/(measurement at enrollment)	Baseline and 24 weeks