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NCT03621553PHASE4Recruiting

Vitamin D Homeostasis in Sarcoidosis

University of Texas Southwestern Medical Center

Start Date

7/1/2010

Completion Date

12/30/2026

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.

Detailed 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.

Eligibility Criteria

Age Range: 21 years to No maximum

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

Interventions

DRUG

Ergocalciferol

DRUG

Placebo

DRUG

Calcium Citrate with Vitamin D2

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Conditions

SarcoidosisVitamin D Insufficiency

Locations

University of Texas Southwestern Medical Center, and Parkland Health and Hospital System

Dallas, Texas 75390-9034

United States