Vitamin D3 in Patients With Sickle Cell Disease

NCT03012555 | Completed DMC

• 1 other identifier: GCO 13-1056
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Keywords

Sickle Cell Disease; Vitamin D

Outcome Measures

Primary Outcomes (1)

• 25(OH)D level

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

  12 months

Secondary Outcomes (2)

• Dexa Scan

  12-18 months

• CRP level

  12 months

Study Arms (1)

Sickle Cell Disease and Vitamin D deficiency

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult Patients (18 years and older) with a diagnosis of sickle cell disease by hemoglobin electrophoresis

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and urine

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jena Simon, MS

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 6, 2017
• Study Start: October 1, 2014
• Primary Completion: August 11, 2016
• Study Completion: August 11, 2016
• Last Updated: January 19, 2018

Record last verified: 2018-01

Locations

US (1)