Vitamin D Homeostasis in Sarcoidosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-01

Study Completion Date

2026-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sarcoidosis Vitamin D Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Vitamin-D insufficient subjects will receive either vitamin D2 repletion or placebo Vitamin-D sufficient subjects will be observed without treatment.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Groups separated by a) use / non-use of oral prednisone, and b) status of serum 25-hydroxy-vitamin-D level (sufficient or insufficient). Those who are vitamin-D insufficient will be randomized to receive either vitamin D2 or placebo.

Study Groups

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Low vit-D, Ergocalciferol

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).

Group Type EXPERIMENTAL

Ergocalciferol

Intervention Type DRUG

Vitamin D2 50,000 units

Calcium Citrate with Vitamin D2

Intervention Type DRUG

To meet the recommended minimum daily dietary requirements

Low vit-D, Placebo

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).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Sugar pill manufactured to mimic ergocalciferol 50,000 units

Calcium Citrate with Vitamin D2

Intervention Type DRUG

To meet the recommended minimum daily dietary requirements

Normal vit-D, control

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).

Group Type OTHER

Calcium Citrate with Vitamin D2

Intervention Type DRUG

To meet the recommended minimum daily dietary requirements

Interventions

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Ergocalciferol

Vitamin D2 50,000 units

Intervention Type DRUG

Placebo

Sugar pill manufactured to mimic ergocalciferol 50,000 units

Intervention Type DRUG

Calcium Citrate with Vitamin D2

To meet the recommended minimum daily dietary requirements

Intervention Type DRUG

Other Intervention Names

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Vitamin D2 Placebo oral tablets Citracal

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No