Vitamin D3 in Patients With Sickle Cell Disease | NCT03012555

Studies
Vitamin D3 in Patients With Sickle Cell Disease

NCT03012555

Sponsor

Icahn School of Medicine at Mount Sinai

Status

Completed

Last Update Posted

Jan 19, 2018Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Sickle Cell Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Aug 11, 2016Actual

Completion Date

Aug 11, 2016Actual

First Submitted Date

Jan 4, 2017

First Submission Date that Met QC Criteria

Jan 4, 2017

First Posted Date

Jan 6, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2018

Last Update Posted Date

Jan 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Actual

Label	Type	Description	Intervention Names
Sickle Cell Disease and Vitamin D deficiency

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
25(OH)D level	Amount of vitamin D to correct vitamin D deficiency in patients with sickle cell disease	12 months

Secondary Outcomes

Measure	Description	Time Frame
Dexa Scan	Change in bone remineralization after 12 months of vitamin D supplementation	12-18 months
CRP level	Medical record abstraction for CRP levels to indicate changes in inflammation

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jena Simon, MS	Icahn School of Medicine at Mount Sinai	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Icahn School of Medicine at Mount Sinai		New York	New York	10029	United States

Condition Browse Module

MeSH Terms

ID	Term
D000755	Anemia, Sickle Cell

Ancestor Terms

ID	Term
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia
D006402	Hematologic Diseases

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