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Vitamin D3 in Patients With Sickle Cell Disease

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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

Tracking Information
First Submitted Date January 4, 2017
First Posted Date January 6, 2017
Last Update Posted Date January 19, 2018
Study Start Date October 2014
Actual Primary Completion Date August 11, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 4, 2017)
25(OH)D level [ Time Frame: 12 months ]
Amount of vitamin D to correct vitamin D deficiency in patients with sickle cell disease
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 4, 2017)
  • Dexa Scan [ Time Frame: 12-18 months ]
    Change in bone remineralization after 12 months of vitamin D supplementation
  • CRP level [ Time Frame: 12 months ]
    Medical record abstraction for CRP levels to indicate changes in inflammation
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vitamin D3 in Patients With Sickle Cell Disease
Official Title Nutritional Vitamin D3 in Patients With Sickle Cell Disease
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood and urine
Sampling Method Non-Probability Sample
Study Population Adult Patients (18 years and older) with a diagnosis of sickle cell disease by hemoglobin electrophoresis
Condition Sickle Cell Disease
Intervention Not Provided
Study Groups/Cohorts Sickle Cell Disease and Vitamin D deficiency
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 4, 2017)
50
Original Actual Enrollment Same as current
Actual Study Completion Date August 11, 2016
Actual Primary Completion Date August 11, 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03012555
Other Study ID Numbers GCO 13-1056
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Icahn School of Medicine at Mount Sinai
Study Sponsor Icahn School of Medicine at Mount Sinai
Collaborators Not Provided
Investigators
Principal Investigator: Jena Simon, MS Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date January 2018