Vitamin D Homeostasis in Sarcoidosis

Phase 4RecruitingNCT03621553

University of Texas Southwestern Medical Center90 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Sarcoidosis Vitamin D Insufficiency

Interventions

ErgocalciferolDRUG

Vitamin D2 50,000 units

PlaceboDRUG

Sugar pill manufactured to mimic ergocalciferol 50,000 units

Calcium Citrate with Vitamin D2DRUG

To meet the recommended minimum daily dietary requirements

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Dallas, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Change in lung function from baseline

(Measurement at end of study)/(measurement at enrollment)

Time frame: Baseline and 24 weeks

Secondary Outcomes

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).

Time frame: Baseline, 12 and 24 weeks

Change in six minute walk distance

(Measurement at end of study)/(measurement at enrollment)

Time frame: Baseline and 24 weeks

Change in blood cell counts from complete blood count (CBC)

(Measurement at study point)/(initial measurement at enrollment)

Time frame: Baseline, 12 and 24 weeks

Change in metabolic profile from complete metabolic panel (CMP)

(Measurement at study point)/(initial measurement at enrollment)

Time frame: Baseline, 12 and 24 weeks

Change in serum vitamin-D metabolite concentration

(Measurement at study point)/(initial measurement at enrollment)

Time frame: Baseline, 12 and 24 weeks

Change in serum angiotensin converting enzyme (ACE) concentration

(Measurement at study point)/(initial measurement at enrollment)

Central Contacts

Connie Hsia, MD

CONTACT

2146483426 Connie.Hsia@utsouthwestern.edu

Khashayar Sakhaee, MD

CONTACT

2146480324 Khashayar.Sakhaee@utsouthwestern.edu

Data from ClinicalTrials.gov

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