Vitamin D Homeostasis in Sarcoidosis

Study ID
STU 062010-055

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Connie Hsia
214-648-3426
connie.hsia@utsouthwestern.edu

Principal Investigator
Connie Hsia

Summary

Specific aim 1
Study Design: establish a clinical registry of patients with sarcoidosis
Study Subjects: Patients with sarcoidosis will be recruited from the Sarcoidosis Clinic and Dermatology Clinic at Parkland Hospital. enrollment for this study aim will be ongoing. Results from laboratory indices performed prior to enrollment as part of standard of care will be obtained from existing patient charts and the tests will not be repeated.

Specific aim 2
Study Design: Cross-sectional pilot study to determine the relationship between endogenous vitamin-D stores and the severity and progression of granulomatous inflammation in two groups of subjects: those with vitamin D insufficiency and those with normal vitamin D levels. Vitamin D will be provided free of charge to study subjects by the study investigators.
Study Subjects: 25 patients from aim 1 who have not been treated with conventional anti-inflammatory or immunosuppressant drugs, or who have been off such treatment for at least 1 month at the time of evaluation will participate in a six month pilot study. We anticipate that eligible patients will have newly diagnosed or early disease, predominantly skin or lymph node involvement, or lung involvement with relatively normal pulmonary function. The need for immediate conventional treatment will be assessed individually.

Specific aim 1
initial evaluation of disease activity:
1) Complete history and physical examination. a clinical score based on the number and severity of organ involvement will be developed. Completion of the initial evaluation of disease activity will take 1-2 weeks.
2) Laboratory indices
3) organ-specific assessment

Specific aim 2
3-month assessment
after initial assessment in aim 1, eligible patients will be followed without treatment for at least 3 months (observation period). Then clinical and selected laboratory parameters will be re-assessed at a 4-hour outpatient visit in order to derive a baseline rate of disease progression; these selected laboratory parameters include:
* as in aim 1: Blood tests (~4 tablespoons), urine tests, 111in-DTPa0-octreotide scan and pulmonary function testing.
Following the initial 3-month observation period, patients with vitamin-D insufficiency (serum 25-oH-D [Less Than]30 ng/ml) will be supplemented with generic ergocalciferol (Vitamin D2) 50,000 u orally once a week (~7,000u per day) for 3 months (supplementation period). Following the initial 3-month observation period, patients with normal vitamin-D stores (serum 25-oH-D [GreaterThanorequalTo]30 ng/ml) will be followed another 3 months without treatment.

4.5 -month assessment (6 weeks post-treatment)
* Serum calcium, 25-oH-D and 1,25-oH-D levels will be measured 6 weeks after the initiation of treatment in subjects with vitamin-D insufficiency (~ 1 tablespoon of blood will be drawn at each visit). each outpatient visit will take ~1 hour.

6-month assessment
at the end of the 3 month supplemental period, all clinical and laboratory indices (except the TB skin test) will be repeated:
* as in aim 1: Blood tests (~5 tablespoons), urine tests, bone mineral density, 111in-DTPa0-octreotide scan and chest CT

end of study Procedures
all subjects will continue with standard of care treatment as deemed necessary by their physician.

Participant Eligibility

Aim1:
1) Sarcoidosis (stage I-III) diagnosed by tissue biopsy showing non-caseating granulomatous inflammation without evidence of lymphoma, TB or fungal infections.
2) Negative TB skin test.
3) There is no selection for gender, ethnicity or age over 21 years. Based on experience we expect most eligible patients to be African-American.

Aim 2:
20-25 patients from Aim 1 who have not been treated with conventional anti-inflammatory or immunosuppressant drugs, or who have been off such treatment for at least 1 month at the time of evaluation.