Vitamin D Supplementation in Children With Sickle Cell Disease

NCT03417947 | Completed Phase 3

• 1 other identifier: ND
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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 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

Sickle Cell Disease

Keywords

Bolus supplementation; Pilot randomised controlled trial; Vitamin D

Outcome Measures

Primary Outcomes (1)

• Mean change in total serum 25-hydroxyvitamin D levels

  Group difference in the mean change in total serum 25OHD from baseline to 3 months.

  3 months

Secondary Outcomes (1)

• Vitamin D sufficiency

  3 months

Other Outcomes (23)

• Hypercalciuria

  7 days post-intervention

• Hypercalcemia

  3 months

• Serum 25-hydroxyvitamin D levels

  3 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo identical to the vitamin D bolus in taste and appearance. The placebo will be administered once, at the beginning of the study. The oral liquid placebo will be prepared at the Pharmacy in coded syringes and will be administered to the participants by a nurse at the sickle cell disease Clinic.

Dietary Supplement: Placebo

Vitamin D bolus

EXPERIMENTAL

The vitamin D bolus is an oral liquid supplement that will be administered once, at the beginning of the study. The oral liquid vitamin D bolus will be prepared at the Pharmacy in coded syringes and will be administered to the participants by a nurse at the sickle cell disease Clinic.The dose of vitamin D3 contained in the bolus is 300 000 IU.

Dietary Supplement: Vitamin D bolus

Interventions

Vitamin D bolus DIETARY_SUPPLEMENT

One single oral liquid vitamin D3 supplement of 300 000 IU

Also known as: Cholecalciferol

Vitamin D bolus

Placebo DIETARY_SUPPLEMENT

Placebo identical in taste and appearance to the vitamin D bolus

Placebo

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged between 5 and 17 years old who are followed up at the SCD Clinic, CHU Sainte-Justine, Montreal, Canada.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Euro-Pharm: collaborator

Study Sites (1)

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (1)

• Soe HHK, Abas AB, Than NN, Ni H, Singh J, Said ARBM, Osunkwo I. Vitamin D supplementation for sickle cell disease. Cochrane Database Syst Rev. 2020 May 28;5(5):CD010858. doi: 10.1002/14651858.CD010858.pub3.

  PMID: 32462740 DERIVED

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Genevieve Mailhot, PhD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Applied Clinical Research Unit of Sainte-Justine UHC will generate the randomisation scheme. Group allocation codes will be held in a secure location with a restricted access by the Central pharmacy (Sainte-Justine UHC). All participants and research personnel, including the nurse, research trainee and research team will be blinded to group assignment. The supplier Euro-Pharm will provide the placebo and vitamin D3 preparations in coded bottles. Pharmacy will prepare the 6-mL bolus in coded syringes following the randomisation scheme.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: This is a randomised, quadruble-blind, placebo-controlled, parallel-group trial of vitamin D3 bolus supplementation.

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 31, 2018
• Study Start: November 30, 2018
• Primary Completion: September 30, 2019
• Study Completion: September 30, 2019
• Last Updated: March 23, 2020

Record last verified: 2020-03

Locations

CA (1)