Clinical trial NCT03012555: Vitamin D3 in Patients With Sickle Cell Disease
Official title: Nutritional Vitamin D3 in Patients With Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Keywords: Sickle Cell Disease
Vitamin D
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Patients (18 years and older) with a diagnosis of sickle cell disease by hemoglobin electrophoresis

Brief summary: There are approximately 90,000 individuals in the United States with sickle cell disease (SCD). Studies have shown that up to 98 percent of patients with Sickle Cell Disease have a vitamin D deficiency, defined as a 25-hydroxyvitamin D level (25(OH)D) less than or equal to 20 ng/mL. As a result, of low bone density, patients may develop osteonecrosis, chronic inflammation and related pain. This study will be coordinated with patients' regularly scheduled visits for medical care and will require patients to submit blood sample at the start of the study and at 3, 6, 9, AND 12 month visits. Patients will also be scheduled for a bone density measurement (DXA scan) at the start of the study and after 12 months of supplementation to assess for any bone re-mineralization. Thus, the main purpose of this study is to find the amount of nutritional vitamin D that needs to be taken by patients with sickle cell disease in order to correct vitamin D deficiency. The study will also test whether vitamin D supplements improve bone health and reduce inflammation.

Detailed description: This is an observational cohort study to follow vitamin D levels over time in patients with sickle cell disease receiving doses of vitamin D as part of their clinical care for vitamin D deficiency.

Eligibility criteria: Inclusion Criteria:

* Adult patients (18 years and older)
* Diagnosis of sickle cell disease by hemoglobin electrophoresis (HbSS, hematopoietic blood stem cell \[HbSC\], Sickle cell b0 Thalassemia, Sickle cell b+ Thalassemia)
* Able to give informed consent
* Any race/ethnicity/socioeconomic status

Exclusion Criteria:

* Pediatric patient (less than 18 years of age)
* Unable to give informed consent
* Untreated primary hyperparathyroidism (ICD9 codes 252.01XX and 252.00XX)
* hypercalcemia (serum calcium level \> 11 mg/dl; ICD9 codes 275.42XX, 259.3XX, 252.00F)
* Pregnancy: a urine pregnancy test, or a serum pregnancy test, will be obtained at the time of enrollment in addition to reviewing the medical record; pregnant patients will be excluded because they should not undergo DXA scanning
* Patients taking atorvastatin, thiazide diuretics and digoxin, which are medications that can interact with vitamin D
* Non-English speakers

Primary outcomes:
measure: 25(OH)D level
timeFrame: 12 months
Secondary outcomes:
measure: Dexa Scan
timeFrame: 12-18 months
measure: CRP level
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Jena Simon, MS
role: PRINCIPAL_INVESTIGATOR
References: