Vitamin D Homeostasis in Sarcoidosis

The University of Texas System (UT)

Status and phase: Enrolling; Phase 4

Conditions: Sarcoidosis; Vitamin D Insufficiency

Treatments: Drug: Calcium Citrate with Vitamin D2; Drug: Placebo; Drug: Ergocalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT03621553

STU 062010-055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

90 participants in 3 patient groups, including a placebo group

Low vit-D, Ergocalciferol

Experimental group

Description:

Low serum vitamin D level, split by use or non-use of systemic corticosteroid. Vitamin D2 (Ergocalciferol) 50,000 units will be given by mouth once a week for 12 weeks, then once a month for 12 weeks. Daily dietary requirement (calcium citrate with vitamin D2 (200 mg/250 Units tablets, 4 tablets per day) will be given by mouth for 24 weeks).

Treatment:

Drug: Ergocalciferol

Drug: Calcium Citrate with Vitamin D2

Low vit-D, Placebo

Placebo Comparator group

Description:

Low serum vitamin D level, split by use or non-use of systemic corticosteroid. Placebo capsules of identical size and appearance will be given by mouth once a week for 12 weeks, then once a month for 12 weeks. Daily dietary requirement (calcium citrate with vitamin D2 (200 mg/250 Units tablets, 4 tablets per day) will be given by mouth for 24 weeks).

Treatment:

Drug: Placebo

Drug: Calcium Citrate with Vitamin D2

Normal vit-D, control

Other group

Description:

Normal serum vitamin D level, split by use or non-use of systemic corticosteroid. Daily dietary requirement (calcium citrate with vitamin D2 (200 mg/250 Units tablets, 4 tablets per day) will be given by mouth for 24 weeks).

Treatment:

Drug: Calcium Citrate with Vitamin D2