SarcoidosisPhase 4NCT03621553
Vitamin D Homeostasis in Sarcoidosis
A Phase 4 study testing Ergocalciferol and Calcium Citrate with Vitamin D2 in people with Sarcoidosis and Vitamin D Insufficiency, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Sarcoidosis, Vitamin D Insufficiency
- What is being tested?
- Ergocalciferol and Calcium Citrate with Vitamin D2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2010to 30 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Southwestern Medical Center, and Parkland Health and Hospital System
Dallas, Texas, 75390-9034
Connie Hsia, MD
Khashaya Sakhaee, MD
About this study
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.
- Conditions
- Sarcoidosis, Vitamin D Insufficiency
- Being tested
- Ergocalciferol, Placebo, Calcium Citrate with Vitamin D2
- Medical subject headings
- Sarcoidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgocalciferolDrug
Also called Vitamin D2
Vitamin D2 50,000 units
PlaceboDrug
Also called Placebo oral tablets
Sugar pill manufactured to mimic ergocalciferol 50,000 units
Calcium Citrate with Vitamin D2Drug
Also called Citracal
To meet the recommended minimum daily dietary requirements
| Study group | Role | What they receive |
|---|---|---|
| Low vit-D, Ergocalciferol | Experimental | 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). Receives: Drug: Ergocalciferol; Drug: Calcium Citrate with Vitamin D2 |
| Low vit-D, Placebo | Placebo comparator | 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). Receives: Drug: Placebo; Drug: Calcium Citrate with Vitamin D2 |
| Normal vit-D, control | Other | 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). Receives: Drug: Calcium Citrate with Vitamin D2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lung function from baseline
(Measurement at end of study)/(measurement at enrollment)
Measured: Baseline and 24 weeks
Secondary outcomes (16)
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).
Measured: Baseline, 12 and 24 weeks
Change in six minute walk distance
(Measurement at end of study)/(measurement at enrollment)
Measured: Baseline and 24 weeks
Change in blood cell counts from complete blood count (CBC)
(Measurement at study point)/(initial measurement at enrollment)
Measured: Baseline, 12 and 24 weeks
Change in metabolic profile from complete metabolic panel (CMP)
(Measurement at study point)/(initial measurement at enrollment)
Measured: Baseline, 12 and 24 weeks
Change in serum vitamin-D metabolite concentration
(Measurement at study point)/(initial measurement at enrollment)
Measured: Baseline, 12 and 24 weeks
Change in serum angiotensin converting enzyme (ACE) concentration
(Measurement at study point)/(initial measurement at enrollment)
Measured: Baseline, 12 and 24 weeks
Change in serum serum gamma-globulin concentration
(Measurement at study point)/(initial measurement at enrollment)
Measured: Baseline, 12 and 24 weeks
Change in serum C-reactive protein (CRP) concentration
(Measurement at study point)/(initial measurement at enrollment)
Measured: Baseline, 12 and 24 weeks
Change in serum tumor Necrosis factor-alpha (TNF-alpha) concentration
(Measurement at study point)/(initial measurement at enrollment)
Measured: Baseline, 12 and 24 weeks
Change in serum interferon-gamma (IFN-gamma) concentration
(Measurement at study point)/(initial measurement at enrollment)
Measured: Baseline, 12 and 24 weeks
Changes in serum interleukin concentration
(Measurement at study point)/(initial measurement at enrollment)
Measured: Baseline, 12 and 24 weeks
Change in 24 hour urine calcium/creatinine ratio
(Measurement at study point)/(initial measurement at enrollment)
Measured: Baseline, 12 and 24 weeks
Change in 24 hour urine deoxypyridinoline concentration
(Measurement at study point)/(initial measurement at enrollment)
Measured: 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)
Measured: Baseline and 24 weeks
Change in Fluoro-deoxyglucose (FDG) uptake on PET/CT
(Measurement at end of study)/(measurement at enrollment
Measured: Baseline and 24 weeks
Change in bone density z-score
(Measurement at end of study)/(measurement at enrollment)
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Jul 2010
- Primary completionDec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Vitamin-D insufficient subjects will receive either vitamin D2 repletion or placebo Vitamin-D sufficient subjects will be observed without treatment.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Connie C W Hsia, University of Texas Southwestern Medical Center
- Investigators
- Connie Hsia, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621553
- Sponsor's protocol ID
- STU 062010-055
- Status last verified
- Aug 2026
- First submitted
- 17 Jul 2018
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data for primary and secondary outcome measures will be made available.
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 27053725Vieth 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 15225842Bolland 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 24157819Kamphuis 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Homeostasis in Sarcoidosis
- ClinicalTrials.gov ID
- NCT03621553
- Acronym / sponsor ID
- STU 062010-055
- Conditions
- Sarcoidosis, Vitamin D Insufficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2010 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Vitamin-D insufficient subjects will receive either vitamin D2 repletion or placebo Vitamin-D sufficient subjects will be observed without treatment.
| Arm | Type | Receives |
|---|---|---|
| Low vit-D, Ergocalciferol | Experimental | Drug: Ergocalciferol, Drug: Calcium Citrate with Vitamin D2Low 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). |
| Low vit-D, Placebo | Placebo comparator | Drug: Placebo, Drug: Calcium Citrate with Vitamin D2Low 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). |
| Normal vit-D, control | Other | Drug: Calcium Citrate with Vitamin D2Normal 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). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErgocalciferolAlso: Vitamin D2Vitamin D2 50,000 units | Drug | Low vit-D, Ergocalciferol |
| PlaceboAlso: Placebo oral tabletsSugar pill manufactured to mimic ergocalciferol 50,000 units | Drug | Low vit-D, Placebo |
| Calcium Citrate with Vitamin D2Also: CitracalTo meet the recommended minimum daily dietary requirements | Drug | Low vit-D, Ergocalciferol, Low vit-D, Placebo, Normal vit-D, control |
Primary outcome
Change in lung function from baseline
Time frame: Baseline and 24 weeks
(Measurement at end of study)/(measurement at enrollment)
16 secondary outcomes
Change in King's Sarcoidosis Questionnaire Score
Time frame: Baseline, 12 and 24 weeks
Change in six minute walk distance
Time frame: Baseline and 24 weeks
Change in blood cell counts from complete blood count (CBC)
Time frame: Baseline, 12 and 24 weeks
Change in metabolic profile from complete metabolic panel (CMP)
Time frame: Baseline, 12 and 24 weeks
Change in serum vitamin-D metabolite concentration
Time frame: Baseline, 12 and 24 weeks
Change in serum angiotensin converting enzyme (ACE) concentration
Time frame: Baseline, 12 and 24 weeks
Change in serum serum gamma-globulin concentration
Time frame: Baseline, 12 and 24 weeks
Change in serum C-reactive protein (CRP) concentration
Time frame: Baseline, 12 and 24 weeks
Change in serum tumor Necrosis factor-alpha (TNF-alpha) concentration
Time frame: Baseline, 12 and 24 weeks
Change in serum interferon-gamma (IFN-gamma) concentration
Time frame: Baseline, 12 and 24 weeks
Changes in serum interleukin concentration
Time frame: Baseline, 12 and 24 weeks
Change in 24 hour urine calcium/creatinine ratio
Time frame: Baseline, 12 and 24 weeks
Change in 24 hour urine deoxypyridinoline concentration
Time frame: Baseline, 12 and 24 weeks
Change in fractional lung tissue volume on computed/positron emission tomography (PET/CT)
Time frame: Baseline and 24 weeks
Change in Fluoro-deoxyglucose (FDG) uptake on PET/CT
Time frame: Baseline and 24 weeks
Change in bone density z-score
Time frame: Baseline and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Results publication: PubMed 27053725Capolongo 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.
- Results publication: PubMed 15225842Vieth 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.
- Results publication: PubMed 24157819Bolland 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.
- Results publication: PubMed 24753153Kamphuis 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.
- Individual participant dataSharing planned: Yes. De-identified participant data for primary and secondary outcome measures will be made available.
Related trials for Sarcoidosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
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A Study of Brepocitinib in Adults With Cutaneous Sarcoidosis
Cutaneous Sarcoidosis
Not yet recruitingPhase 2
An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
Pulmonary Sarcoidosis
Not yet recruitingPhase 2
LAM-001 for the Treatment of Sarcoidosis Associated Pulmonary Hypertension (SAPH)
Sarcoidosis Associated Pulmonary Hypertension
RecruitingObservational study
Prognostic Value of Clinical Cardiovascular MRI
Sarcoidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Connie Hsia, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ergocalciferol and Calcium Citrate with Vitamin D2 in people with Sarcoidosis and Vitamin D Insufficiency, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Connie Hsia, MD (2146483426, Connie.Hsia@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lung function from baseline (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03621553, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.