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Vitamin D Supplementation in Children With Sickle Cell Disease

NCT03417947 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-03-23

No results posted yet for this study

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 one of the most common. Symptoms of vitamin D deficiency are similar to those of SCD and include chronic pain and bone complications. Correcting vitamin D nutrition of children with SCD represents a treatment that will improve their health. A single oral high-dose of vitamin D3 will be given to SCD children during one of their follow-up visits at the SCD clinic of CHU Sainte-Justine, Montreal, Canada. This mode of administration was chosen to ensure a better adherence to the treatment. The investigators will determine whether this dose is safe and its administration feasible in clinic. The impact of this dose on blood vitamin D and calcium, urinary calcium, growth, inflammation, bone health, pain and quality of life will also be assessed. This study intends to propose a new intervention to improve the nutrition of children with this disease.

Conditions

Interventions

DIETARY_SUPPLEMENT

Vitamin D bolus

One single oral liquid vitamin D3 supplement of 300 000 IU

DIETARY_SUPPLEMENT

Placebo

Placebo identical in taste and appearance to the vitamin D bolus

Sponsors & Collaborators

  • Euro-Pharm

    collaborator UNKNOWN

  • St. Justine's Hospital

    lead OTHER

Principal Investigators

  • Genevieve Mailhot, PhD · St. Justine's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2019-09-30
Completion
2019-09-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03417947 on ClinicalTrials.gov