Vitamin D Homeostasis in Sarcoidosis

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT03621553
Phase
PHASE4
Status
Recruiting
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Conditions

  • Sarcoidosis
  • Vitamin D Insufficiency

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 1, 2010
Status verified
Dec 2025
Primary completion
Feb 28, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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).
  • Placebo Comparator: 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).
  • Other: 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).

Primary Outcome Measure

Change in lung function from baseline [ Time Frame: Baseline and 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Southwestern Medical Center, and Parkland Health and Hospital SystemDallasTexas75390-9034
Connie Hsia, MD (PRINCIPAL_INVESTIGATOR)
Khashaya Sakhaee, MD (SUB_INVESTIGATOR)

Find similar trials in Dallas, TX

By research site
University of Texas Southwestern Medical Center, and Parkland Health and Hospital System· Dallas, TX

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