Recruiting

Vitamin-D Repletion

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT03621553

Conditions

Sarcoidosis

Vitamin D Insufficiency

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Ergocalciferol

Placebo

Calcium Citrate with Vitamin D2

Study Details

Brief 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.

Conditions

Sarcoidosis

Vitamin D Insufficiency

Study ID

NCT03621553

Start date

Jul 1, 2010

Status verified date

Aug, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

Ergocalciferol

Vitamin D2 50,000 units

Placebo

Sugar pill manufactured to mimic ergocalciferol 50,000 units

Calcium Citrate with Vitamin D2

To meet the recommended minimum daily dietary requirements

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Connie Hsia, MD

2146483426Connie.Hsia@utsouthwestern.edu

Khashayar Sakhaee, MD

2146480324Khashayar.Sakhaee@utsouthwestern.edu

Locations

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

Recruiting

Dallas, Texas, United States, 75390-9034

Principal Investigator:

Connie Hsia, MD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-09-03.