Clincosm LogoSign in Get a demo

Vitamin D3 in Patients With Sickle Cell Disease

Sponsor
Icahn School of Medicine at Mount Sinai (Other)
Overall Status
Completed
CT.gov ID
NCT03012555
Collaborator
(none)
50
Enrollment
1
Location
22.3
Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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

    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 :
    Oct 1, 2014
    Actual Primary Completion Date :
    Aug 11, 2016
    Actual Study Completion Date :
    Aug 11, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Sickle Cell Disease and Vitamin D deficiency

    Outcome Measures

    Primary Outcome Measures

    1. 25(OH)D level [12 months]

      Amount of vitamin D to correct vitamin D deficiency in patients with sickle cell disease

    Secondary Outcome Measures

    1. Dexa Scan [12-18 months]

      Change in bone remineralization after 12 months of vitamin D supplementation

    2. CRP level [12 months]

      Medical record abstraction for CRP levels to indicate changes in inflammation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    • Principal Investigator: Jena Simon, MS, Icahn School of Medicine at Mount Sinai

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Icahn School of Medicine at Mount Sinai
    ClinicalTrials.gov Identifier:
    NCT03012555
    Other Study ID Numbers:
    • GCO 13-1056
    First Posted:
    Jan 6, 2017
    Last Update Posted:
    Jan 19, 2018
    Last Verified:
    Jan 1, 2018
    Keywords provided by Icahn School of Medicine at Mount Sinai
    Sickle Cell Disease
    Vitamin D
    Additional relevant MeSH terms:
    Anemia, Sickle Cell

    Study Results

    No Results Posted as of Jan 19, 2018