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RecruitingNCT03621553Updated Sep 3, 2026

Vitamin D Homeostasis in Sarcoidosis

A Phase 4 interventional study of Ergocalciferol and Placebo in Sarcoidosis and Vitamin D Insufficiency, sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.

Sponsored by University of Texas Southwestern Medical Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Sarcoidosis
  • Vitamin D Insufficiency

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03

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
90 participants (estimated)

Study 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).

    Drug: Ergocalciferol · Drug: Calcium Citrate with Vitamin D2

  • 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).

    Drug: Placebo · Drug: Calcium Citrate with Vitamin D2

  • 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).

    Drug: Calcium Citrate with Vitamin D2

Interventions

  • DrugErgocalciferol

    Vitamin D2 50,000 units

    Also known as: Vitamin D2

  • DrugPlacebo

    Sugar pill manufactured to mimic ergocalciferol 50,000 units

    Also known as: Placebo oral tablets

  • DrugCalcium Citrate with Vitamin D2

    To meet the recommended minimum daily dietary requirements

    Also known as: Citracal

05

What researchers measure

Primary outcomes

  1. Change in lung function from baseline

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

    Time frame: Baseline and 24 weeks

Secondary outcomes

  1. Change in King's Sarcoidosis Questionnaire Score

    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).

    Time frame: Baseline, 12 and 24 weeks

  2. Change in six minute walk distance

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

    Time frame: Baseline and 24 weeks

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

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

    Time frame: Baseline, 12 and 24 weeks

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

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

    Time frame: Baseline, 12 and 24 weeks

  5. Change in serum vitamin-D metabolite concentration

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

    Time frame: Baseline, 12 and 24 weeks

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

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

    Time frame: Baseline, 12 and 24 weeks

  7. Change in serum serum gamma-globulin concentration

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

    Time frame: Baseline, 12 and 24 weeks

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

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

    Time frame: Baseline, 12 and 24 weeks

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

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

    Time frame: Baseline, 12 and 24 weeks

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

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

    Time frame: Baseline, 12 and 24 weeks

  11. Changes in serum interleukin concentration

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

    Time frame: Baseline, 12 and 24 weeks

  12. Change in 24 hour urine calcium/creatinine ratio

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

    Time frame: Baseline, 12 and 24 weeks

  13. Change in 24 hour urine deoxypyridinoline concentration

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

    Time frame: Baseline, 12 and 24 weeks

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

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

    Time frame: Baseline and 24 weeks

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

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

    Time frame: Baseline and 24 weeks

  16. Change in bone density z-score

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

    Time frame: Baseline and 24 weeks

06

Study locations

1 of 1 sites recruiting
  • University of Texas Southwestern Medical Center, and Parkland Health and Hospital System
    Dallas, Texas 75390-9034, United States
    • Connie Hsia, MD · Principal investigator
    • Khashaya Sakhaee, MD · Sub investigator
    Recruiting
07

References and documents

Publications

  • Capolongo G, Xu LH, Accardo M, Sanduzzi A, Stanziola AA, Colao A, Agostini C, Zacchia M, Capasso G, Adams-Huet B, Moe OW, Maalouf NM, Sakhaee K, Hsia CC. Vitamin-D status and mineral metabolism in two ethnic populations with sarcoidosis. J Investig Med. 2016 Jun;64(5):1025-34. doi: 10.1136/jim-2016-000101. Epub 2016 Apr 6. PubMed 27053725 ↗
  • Vieth R. Why the optimal requirement for Vitamin D3 is probably much higher than what is officially recommended for adults. J Steroid Biochem Mol Biol. 2004 May;89-90(1-5):575-9. doi: 10.1016/j.jsbmb.2004.03.038. PubMed 15225842 ↗
  • Bolland MJ, Wilsher ML, Grey A, Horne AM, Fenwick S, Gamble GD, Reid IR. Randomised controlled trial of vitamin D supplementation in sarcoidosis. BMJ Open. 2013 Oct 23;3(10):e003562. doi: 10.1136/bmjopen-2013-003562. PubMed 24157819 ↗
  • Kamphuis LS, Bonte-Mineur F, van Laar JA, van Hagen PM, van Daele PL. Calcium and vitamin D in sarcoidosis: is supplementation safe? J Bone Miner Res. 2014 Nov;29(11):2498-503. doi: 10.1002/jbmr.2262. PubMed 24753153 ↗

Individual participant data

Plan to share: Yes — De-identified participant data for primary and secondary outcome measures will be made available.

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

08

Registry details

Key details

Study ID
NCT03621553
Lead sponsor
University of Texas Southwestern Medical Center
Responsible party
Connie C W Hsia (Professor of Internal Medicine, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Aug 8, 2018
Start date
Jul 1, 2010
Primary completion
Dec 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Sep 3, 2026

Study contacts

Connie Hsia, MD
Contact
Connie.Hsia@utsouthwestern.edu
2146483426
Khashayar Sakhaee, MD
Contact
Khashayar.Sakhaee@utsouthwestern.edu
2146480324
Connie Hsia, MD
principal investigator · University of Texas Southwestern Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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