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
Among 115 studies in Sarcoidosis with a site in United States — 23 open to participants now, 25 under way, 3 of them phase 3. Sarcoidosis · United States.
Among the 115 studies in Sarcoidosis with a site in United States, this one is the 13th largest by planned enrollment of the 69 interventional ones that give a count, is one of 4 that started in 2010, is one of 12 in phase 4, reaches primary completion later than 2 of the 24 other live ones, and was the 70th registered.
271 studies on the registry are indexed under Sarcoidosis; 51 are open to participants now.
This study's planned enrollment of 90 is above the median of 50 across 145 interventional studies indexed under Sarcoidosis.
Browse Sarcoidosis studies →23 of the 115 studies in Sarcoidosis with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 40 Sarcoidosis studies recruiting now, 30 (75%) set no upper age limit and 1 (3%) stop at 75 or younger; 6 take children under 18; 11 take healthy volunteers.
This study: 21 Years and older · all sexes · no healthy volunteers.
The full table on the hub →115 studies; the count open now beside each. This study's row is marked.
First in 1978; this study’s year is marked. 4 started in 2010.
Median enrollment 16 across the 69 interventional studies, 200 across the 46 observational. Of the 72 that completed or were terminated, 30 (42%) have results posted.
16 of 115 have an industry lead sponsor. The 10 most frequent:
University of Texas Southwestern Medical Center is the lead sponsor of 1,010 studies on the registry; 199 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 105 (76%) have results posted.
University of Texas Southwestern Medical Center has 1 study filed under Sarcoidosis — fewer than ten, so there is no comparison to draw.
7 of the studies in Sarcoidosis with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03593759Phase 3Ottawa Heart Institute Research CorporationCardiac Sarcoidosis Randomized Trial | 2026-12 |
| NCT03621553University of Texas Southwestern Medical CenterVitamin D Homeostasis in Sarcoidosis | 2026-12 |
| NCT07159074Duke UniversityRepurposing Tilmanocept for Cardiac Sarcoidosis | 2026-12-01 |
| NCT05171478Johns Hopkins UniversityFull-Field Optical Coherence Tomography (FFOCT) for Evaluation of Bronchoscopic Small Biopsy Specimens | 2026-12-08 |
| NCT06510894University of PennsylvaniaDiagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression | 2026-12-31 |
Among the 115 studies in Sarcoidosis with a site in United States, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
Vitamin D2 50,000 units
Also known as: Vitamin D2
Sugar pill manufactured to mimic ergocalciferol 50,000 units
Also known as: Placebo oral tablets
Drug pages: Calcium Citrate · Ergocalciferols
To meet the recommended minimum daily dietary requirements
Also known as: Citracal
Change in lung function from baseline
(Measurement at end of study)/(measurement at enrollment)
Time frame: Baseline and 24 weeks
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
Change in six minute walk distance
(Measurement at end of study)/(measurement at enrollment)
Time frame: Baseline and 24 weeks
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
Change in metabolic profile from complete metabolic panel (CMP)
(Measurement at study point)/(initial measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
Change in serum vitamin-D metabolite concentration
(Measurement at study point)/(initial measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
Change in serum angiotensin converting enzyme (ACE) concentration
(Measurement at study point)/(initial measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
Change in serum serum gamma-globulin concentration
(Measurement at study point)/(initial measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
Change in serum C-reactive protein (CRP) concentration
(Measurement at study point)/(initial measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
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
Change in serum interferon-gamma (IFN-gamma) concentration
(Measurement at study point)/(initial measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
Changes in serum interleukin concentration
(Measurement at study point)/(initial measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
Change in 24 hour urine calcium/creatinine ratio
(Measurement at study point)/(initial measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
Change in 24 hour urine deoxypyridinoline concentration
(Measurement at study point)/(initial measurement at enrollment)
Time frame: Baseline, 12 and 24 weeks
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
Change in Fluoro-deoxyglucose (FDG) uptake on PET/CT
(Measurement at end of study)/(measurement at enrollment
Time frame: Baseline and 24 weeks
Change in bone density z-score
(Measurement at end of study)/(measurement at enrollment)
Time frame: Baseline and 24 weeks
Plan to share: Yes — De-identified participant data for primary and secondary outcome measures will be made available.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Within 6 months of study completion
Access criteria: Data access requests will be reviewed by an external independent review panel. Requestors will be required to sign a Data Access Agreement.
Started Jul 2010 (actual). Primary completion is estimated for Dec 2026, 197 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Ergocalciferols
University of Texas Southwestern Medical Center →