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Vitamin D3 in Patients With Sickle Cell Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03012555
Recruitment Status : Completed
First Posted : January 6, 2017
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Study Description
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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.

Condition or disease
Sickle Cell Disease

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.
Study Design
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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nutritional Vitamin D3 in Patients With Sickle Cell Disease
Study Start Date : October 2014
Actual Primary Completion Date : August 11, 2016
Actual Study Completion Date : August 11, 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Sickle Cell Disease and Vitamin D deficiency


Outcome Measures
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Primary Outcome Measures :
  1. 25(OH)D level [ Time Frame: 12 months ]
    Amount of vitamin D to correct vitamin D deficiency in patients with sickle cell disease


Secondary Outcome Measures :
  1. Dexa Scan [ Time Frame: 12-18 months ]
    Change in bone remineralization after 12 months of vitamin D supplementation

  2. CRP level [ Time Frame: 12 months ]
    Medical record abstraction for CRP levels to indicate changes in inflammation


Biospecimen Retention:   Samples With DNA
Whole blood and urine

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult Patients (18 years and older) with a diagnosis of sickle cell disease by hemoglobin electrophoresis
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03012555


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Jena Simon, MS Icahn School of Medicine at Mount Sinai
More Information
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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03012555    
Other Study ID Numbers: GCO 13-1056
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018
Keywords provided by Icahn School of Medicine at Mount Sinai:
Sickle Cell Disease
Vitamin D
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn