Vitamin D3 in Patients With Sickle Cell Disease
| Status: | Completed |
|---|---|
| Conditions: | Anemia |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/21/2018 |
| Start Date: | October 2014 |
| End Date: | August 11, 2016 |
Nutritional Vitamin D3 in Patients With Sickle Cell Disease
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.
(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.
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.
sickle cell disease receiving doses of vitamin D as part of their clinical care for vitamin D
deficiency.
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
We found this trial at
1
site
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
Click here to add this to my saved trials
