Status:
COMPLETED
Vitamin D Supplementation in Children With Sickle Cell Disease
Lead Sponsor:
St. Justine's Hospital
Collaborating Sponsors:
Euro-Pharm
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief Summary
Sickle cell disease (SCD) is a genetic disease characterized by abnormal hemoglobin, the main constituent of red blood cells. People with SCD have nutritional deficiencies, and vitamin D deficiency is...
Detailed Description
Vitamin D deficiency is one of the most common nutritional conditions among patients with sickle cell disease (SCD). Since vitamin D deficiency and SCD share common manifestations including chronic pa...
Eligibility Criteria
Inclusion
- Children aged between 5 and 17 years old who are followed up at the SCD Clinic, CHU Sainte-Justine, Montreal, Canada.
Exclusion
- Conditions or use of medications known to interfere with calcium or vitamin D absorption or metabolism
- Known hypercalcemia
- Conditions characterized by a hypersensitivity to vitamin D (e.g. granulomatous disorders)
- Patients clinically diagnosed with rickets or other conditions requiring vitamin D therapy
- History or presence of urolithiasis
- Anticipated difficult follow up
- Patients already enrolled in other investigational studies
- Patients who have recently been hospitalized for severe pain crisis or acute sickle complication in the past 2 weeks
- Patients with unresolved pain issues
Key Trial Info
Start Date :
November 30 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2019
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03417947
Start Date
November 30 2018
End Date
September 30 2019
Last Update
March 23 2020
Active Locations (1)
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1
CHU Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5