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NCT03012555 · ClinicalTrials.gov registry record

Vitamin D3 in Patients With Sickle Cell Disease

A clinical trial, sponsored by Icahn School of Medicine at Mount Sinai.

Completed
Registry status
50
Enrollment target

NCT03012555: Completed study, sponsored by Icahn School of Medicine at Mount Sinai.

NCT03012555 is a clinical trial that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03012555 has completed, sponsored by Icahn School of Medicine at Mount Sinai.

COMPLETED
Registry status
50 participants
Enrollment target

Study 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.

Primary Outcome

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

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2014-10
Est. Completion 2016-08-11

What the finished NCT03012555 record still lists

NCT03012555 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 50 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT03012555 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03012555 about?

NCT03012555 is a clinical study titled "Vitamin D3 in Patients With Sickle Cell Disease". 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 ...

What is the current status of trial NCT03012555?

This trial is currently completed. The enrollment target is 50 participants. The study started on 2014-10. Estimated completion is 2016-08-11.

Who is sponsoring clinical trial NCT03012555?

This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03012555, the US trial registry maintained by the National Library of Medicine. NCT03012555 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.