Vitamin D3 in Patients With Sickle Cell Disease

Status Completed

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03012555
Study type	Observational
Source	Icahn School of Medicine at Mount Sinai
Contact
Status	Completed
Phase	N/A
Start date	October 2014
Completion date	August 11, 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02227472` - Working Memory and School Readiness in Preschool-Aged Children With Sickle Cell Disease
Recruiting	`NCT06301893` - Uganda Sickle Surveillance Study (US-3)
Recruiting	`NCT04398628` - ATHN Transcends: A Natural History Study of Non-Neoplastic Hematologic Disorders
Completed	`NCT02522104` - Evaluation of the Impact of Renal Function on the Pharmacokinetics of SIKLOS ® (DARH)	Phase 4
Recruiting	`NCT04688411` - An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease	N/A
Terminated	`NCT03615924` - Effect of Ticagrelor vs. Placebo in the Reduction of Vaso-occlusive Crises in Pediatric Patients With Sickle Cell Disease	Phase 3
Not yet recruiting	`NCT06300723` - Clinical Study of BRL-101 in Severe SCD	N/A
Recruiting	`NCT03937817` - Collection of Human Biospecimens for Basic and Clinical Research Into Globin Variants
Completed	`NCT04917783` - Health Literacy - Neurocognitive Screening in Pediatric SCD	N/A
Completed	`NCT04134299` - To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease	N/A
Completed	`NCT02580565` - Prevalence of Problematic Use of Equimolar Mixture of Oxygen and Nitrous Oxide and Analgesics in the Sickle-cell Disease
Recruiting	`NCT04754711` - Interest of Nutritional Care of Children With Sickle Cell Disease on Bone Mineral Density and Body Composition	N/A
Completed	`NCT04388241` - Preliminary Feasibility and Efficacy of Behavioral Intervention to Reduce Pain-Related Disability in Pediatric SCD	N/A
Recruiting	`NCT05431088` - A Phase 2/3 Study in Adult and Pediatric Participants With SCD	Phase 2/Phase 3
Completed	`NCT01158794` - Genes Influencing Iron Overload State
Recruiting	`NCT03027258` - Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome	N/A
Withdrawn	`NCT02960503` - Macrolide Therapy to Improve Forced Expiratory Volume in 1 Second in Adults With Sickle Cell Disease	Phase 1/Phase 2
Completed	`NCT02567682` - Drug Interaction Study of GBT440 With Caffeine, S-warfarin, Omeprazole, and Midazolam in Healthy Subjects	Phase 1
Completed	`NCT02620488` - A Brief Laboratory-Based Hypnosis Session for Pain in Sickle Cell Disease	N/A
Completed	`NCT02567695` - A Single-Dose Relative Bioavailability Study Of GBT440 300 mg Capsules in Healthy Subjects	Phase 1