A Phase 3 interventional study of Vitamin D bolus and Placebo in Sickle Cell Disease, sponsored by St. Justine's Hospital. Completed at 1 site in Canada. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2020-03-23.
Sponsored by St. Justine's Hospital · Phase 3, Interventional, and Other
Among 55 studies in Anemia, Sickle Cell with a site in Canada — 15 open to participants now, 22 under way, 7 of them phase 3. Anemia, Sickle Cell · Canada.
Among the 55 studies in Anemia, Sickle Cell with a site in Canada, this one is the 38th largest by enrollment of the 49 interventional ones that give a count, is one of 7 that started in 2018, is one of 14 in phase 3, and was the 24th registered.
1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.
Browse Anemia, Sickle Cell studies →15 of the 55 studies in Anemia, Sickle Cell with a site in Canada are open now. Recruiting first, the newest first:
Biossil Inc. · Sites in Canada
Ages 16–50
Yves Pastore · Sites in Canada
Ages 6 mo–18 yrs
Novo Nordisk A/S · Sites in Canada, United States, Australia and 18 more countries
Ages 12+
Novo Nordisk A/S · Sites in Canada, United States, Egypt and 14 more countries
Ages 2+
Bristol-Myers Squibb · Sites in Canada, United States, France and 2 more countries
Ages 18+ · Healthy volunteers
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 177 Anemia, Sickle Cell studies recruiting now, 64 (36%) set no upper age limit and 97 (55%) stop at 75 or younger; 127 take children under 18; 29 take healthy volunteers.
This study: 5 Years to 17 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
55 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 27 · Phase 3 17 · Phase 4 3
First in 1999; this study’s year is marked. 7 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 42 is close to the median of 40 across 769 interventional studies indexed under Anemia, Sickle Cell.
Median enrollment 81 across the 49 interventional studies, 300 across the 5 observational. Of the 32 that completed or were terminated, 18 (56%) have results posted.
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37 of 55 have an industry lead sponsor. The 10 most frequent:
St. Justine's Hospital is the lead sponsor of 156 studies on the registry; 27 are open to participants now.
St. Justine's Hospital has 1 study filed under Anemia, Sickle Cell — fewer than ten, so there is no comparison to draw.
4 of the studies in Anemia, Sickle Cell with a site in Canada that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06612268Phase 3Novo Nordisk A/SA Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease | 2027-08-27 |
| NCT04018937Emory UniversityEarly Human Leukocyte Antigen (HLA) Matched Sibling Hematopoietic Stem Cell Transplantation | 2026-11 |
| NCT06529042Mount Sinai Hospital, CanadaSCRIPT: Sickle Cell Risk in Pregnancy Tool | 2026-12 |
| NCT06481306Bristol-Myers SquibbA Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease | 2027-01-06 |
Add all 4 to your calendar (.ics) → With an account.
Among the 55 studies in Anemia, Sickle Cell with a site in Canada, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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 pain, poor bone health and chronic systemic inflammation, it is reasonable to postulate that vitamin D deficiency may contribute to these complications. Thus, optimizing vitamin D nutrition represents an inexpensive strategy that may improve vitamin D status and health outcomes in SCD children. The working hypothesis is that administration of a single oral bolus of 300,000 IU of vitamin D3 to SCD children will result in the attainment of vitamin D sufficiency (25OHD levels >75 nmol/L) in 80% of participants after 3 months. The primary objectives are to assess feasibility, acceptability, and safety of the vitamin D3 bolus while secondary objectives are related to the mean change in serum 25OHD from baseline to 3 months post-bolus and its clinical impact. Seventy-two SCD children (5-17 years, SS and SC genotypes) will be randomized to one bolus of 300,000 IU of vitamin D3 or identical placebo. Blood will be collected at baseline and 3-month post-bolus to measure serum 25OHD and calculate the change from baseline at 3 months (efficacy outcomes). Other outcomes include urinary calcium/creatinine ratio and serum calcium (safety), questionnaires (acceptability and musculoskeletal pain) and parameters related to growth, haematology, inflammation and bone health (exploratory outcomes).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
One single oral liquid vitamin D3 supplement of 300 000 IU
Also known as: Cholecalciferol
Placebo identical in taste and appearance to the vitamin D bolus
Mean change in total serum 25-hydroxyvitamin D levels
Group difference in the mean change in total serum 25OHD from baseline to 3 months.
Time frame: 3 months
Vitamin D sufficiency
Difference in the proportion of children with serum 25-hydroxyvitamin D ≥75nmol/L at 3 months
Time frame: 3 months
Hypercalciuria
Number of patients with urinary calcium to creatinine ratio above normal reference range for age
Time frame: 7 days post-intervention
Hypercalcemia
Number of patients with serum calcium above normal reference range for age
Time frame: 3 months
Serum 25-hydroxyvitamin D levels
Number of patients with serum 25-hydroxyvitamin D levels \>250 nmol/L
Time frame: 3 months
Mean change in weight
Group difference in the mean change of weight (kg) from baseline to 3 months.
Time frame: 3 months
Mean change in height
Group difference in the mean change of height (kg) from baseline to 3 months.
Time frame: 3 months
Mean change in hemoglobin
Group difference in the mean change of circulating hemoglobin from baseline to 3 months.
Time frame: 3 months
Mean change in fetal hemoglobin
Group difference in the mean change of circulating fetal hemoglobin from baseline to 3 months.
Time frame: 3 months
Mean change in leucocyte counts
Group difference in the mean change of blood leucocyte counts from baseline to 3 months.
Time frame: 3 months
Mean change in platelet counts
Group difference in the mean change of blood platelet counts from baseline to 3 months.
Time frame: 3 months
Mean change in reticulocyte counts
Group difference in the mean change of blood reticulocyte counts from baseline to 3 months
Time frame: 3 months
Mean change in neutrophil counts
Group difference in the mean change of blood neutrophil counts from baseline to 3 months
Time frame: 3 months
Mean change in mean corpuscular volume
Group difference in the mean change of blood mean corpuscular volume from baseline to 3 months
Time frame: 3 months
Mean change in serum creatinine
Group difference in the mean change of serum creatinine from baseline to 3 months.
Time frame: 3 months
Mean change in serum bilirubin
Group difference in mean change of serum bilirubin from baseline to 3 months.
Time frame: 3 months
Mean change in serum parathyroid hormone
Group difference in mean change of serum parathyroid hormone from baseline to 3 months
Time frame: 3 months
Mean change in serum P1NP
Group difference in mean change of serum amino-terminal propeptide of type I collagen (P1NP) from baseline to 3 months
Time frame: 3 months
Mean change in serum C-telopeptides
Group difference in mean change of serum C-telopeptides from baseline to 3 months
Time frame: 3 months
Mean change in musculoskeletal pain scores
Musculoskeletal pain will be assessed with the Brief Pain Inventory (BPI). Group difference in the mean change in BPI scores.
Time frame: 3 months
Mean change in quality of life scores
Health-related quality of life will be assessed through the Pediatric Quality of life (PedQoL) inventory. Group difference in the mean change in PedQoL scores.
Time frame: 3 months
Sickle cell disease-related complications
Occurrence of sickle cell disease complications affecting bone, the kidneys, the retina, blood vessels, the heart, the lungs, the spleen, the liver and gallbladder during the study period
Time frame: 3 months
Participant recruitment
Percentage of patients recruited from those screened
Time frame: 3 months
Participant retention
Percentage of patients retained for the entire study duration
Time frame: 3 months
Participant compliance
Percentage of patients who comply with the study protocol
Time frame: 3 months
Plan to share: Undecided
Ran from Nov 2018 to primary completion in Sep 2019, 10 months.
Of 35 phase 3 interventional studies under Anemia, Sickle Cell, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 61. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cholecalciferol