Vitamin D3 in Patients With Sickle Cell Disease

Sickle Cell Disease Clinical Trial

Official title:

Nutritional Vitamin D3 in Patients With Sickle Cell Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03012555
• Other study ID #: GCO 13-1056
• Status: Completed
• Phase: N/A
• First received: January 4, 2017
• Last updated: January 17, 2018
• Start date: October 2014
• Est. completion date: August 11, 2016

Study information

• Verified date: January 2018
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 11, 2016
• Est. primary completion date: August 11, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25(OH)D level	Amount of vitamin D to correct vitamin D deficiency in patients with sickle cell disease	12 months
Secondary	Dexa Scan	Change in bone remineralization after 12 months of vitamin D supplementation	12-18 months
Secondary	CRP level	Medical record abstraction for CRP levels to indicate changes in inflammation	12 months