Vitamin D Homeostasis in Sarcoidosis

NCT03621553 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: STU 062010-055
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in lung function from baseline

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

  Baseline and 24 weeks

Secondary Outcomes (16)

• Change in King's Sarcoidosis Questionnaire Score

  Baseline, 12 and 24 weeks

• Change in six minute walk distance

  Baseline and 24 weeks

• Change in blood cell counts from complete blood count (CBC)

  Baseline, 12 and 24 weeks

• Change in metabolic profile from complete metabolic panel (CMP)

  Baseline, 12 and 24 weeks

• Change in serum vitamin-D metabolite concentration

  Baseline, 12 and 24 weeks

Study Arms (3)

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).

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).

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).

Drug: Calcium Citrate with Vitamin D2

Interventions

Placebo DRUG

Sugar pill manufactured to mimic ergocalciferol 50,000 units

Also known as: Placebo oral tablets

Low vit-D, Placebo

Ergocalciferol DRUG

Vitamin D2 50,000 units

Also known as: Vitamin D2

Low vit-D, Ergocalciferol

Calcium Citrate with Vitamin D2 DRUG

To meet the recommended minimum daily dietary requirements

Also known as: Citracal

Low vit-D, Ergocalciferol; Low vit-D, Placebo; Normal vit-D, control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

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

Dallas, Texas, 75390-9034, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 27053725 RESULT

• 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.

  PMID: 15225842 RESULT

• 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.

  PMID: 24157819 RESULT

• 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.

  PMID: 24753153 RESULT

MeSH Terms

Conditions

Sarcoidosis

Interventions

Ergocalciferols; Calcium Citrate

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Calcium Compounds; Inorganic Chemicals; Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Connie Hsia, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Connie Hsia, MD

CONTACT

2146483426; Connie.Hsia@utsouthwestern.edu

Khashayar Sakhaee, MD

CONTACT

2146480324; Khashayar.Sakhaee@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Groups separated by a) use / non-use of oral prednisone, and b) status of serum 25-hydroxy-vitamin-D level (sufficient or insufficient). Those who are vitamin-D insufficient will be randomized to receive either vitamin D2 or placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Model Details: Vitamin-D insufficient subjects will receive either vitamin D2 repletion or placebo Vitamin-D sufficient subjects will be observed without treatment.

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 8, 2018
• Study Start: July 1, 2010
• Primary Completion: February 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, 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.

Locations

US (1)