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NCT Number: NCT03621553

Vitamin D Homeostasis in Sarcoidosis

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.

Recruiting

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Dallas, Texas, 75390-9034, United States

Location status: Recruiting

Location contact

Connie Hsia, MD

PRINCIPAL_INVESTIGATOR

Khashaya Sakhaee, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ergocalciferol

Drug

Vitamin D2 50,000 units

Other names: Vitamin D2

Placebo

Drug

Sugar pill manufactured to mimic ergocalciferol 50,000 units

Other names: Placebo oral tablets

Calcium Citrate with Vitamin D2

Drug

To meet the recommended minimum daily dietary requirements

Other names: Citracal

Primary outcomes

  1. Change in lung function from baseline

    Time frame: Baseline and 24 weeks

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

Secondary outcomes

  1. Change in King's Sarcoidosis Questionnaire Score

    Time frame: Baseline, 12 and 24 weeks

    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).

  2. Change in six minute walk distance

    Time frame: Baseline and 24 weeks

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

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

    Time frame: Baseline, 12 and 24 weeks

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

  4. Change in metabolic profile from complete metabolic panel (CMP)

    Time frame: Baseline, 12 and 24 weeks

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

  5. Change in serum vitamin-D metabolite concentration

    Time frame: Baseline, 12 and 24 weeks

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

  6. Change in serum angiotensin converting enzyme (ACE) concentration

    Time frame: Baseline, 12 and 24 weeks

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

  7. Change in serum serum gamma-globulin concentration

    Time frame: Baseline, 12 and 24 weeks

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

  8. Change in serum C-reactive protein (CRP) concentration

    Time frame: Baseline, 12 and 24 weeks

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

  9. Change in serum tumor Necrosis factor-alpha (TNF-alpha) concentration

    Time frame: Baseline, 12 and 24 weeks

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

  10. Change in serum interferon-gamma (IFN-gamma) concentration

    Time frame: Baseline, 12 and 24 weeks

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

  11. Changes in serum interleukin concentration

    Time frame: Baseline, 12 and 24 weeks

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

  12. Change in 24 hour urine calcium/creatinine ratio

    Time frame: Baseline, 12 and 24 weeks

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

  13. Change in 24 hour urine deoxypyridinoline concentration

    Time frame: Baseline, 12 and 24 weeks

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

  14. Change in fractional lung tissue volume on computed/positron emission tomography (PET/CT)

    Time frame: Baseline and 24 weeks

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

  15. Change in Fluoro-deoxyglucose (FDG) uptake on PET/CT

    Time frame: Baseline and 24 weeks

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

  16. Change in bone density z-score

    Time frame: Baseline and 24 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Connie Hsia, MD

CONTACT

[email protected]

2146483426

Khashayar Sakhaee, MD

CONTACT

[email protected]

2146480324

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Important dates

Study start
2010
Primary completion
2026
Study completion
2026
First posted
Aug 8, 2018
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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