Please select the eligibility criteria that correspond to the clinical trial below.
Title: Vitamin D Intervention in Children With Sickle Cell Disease: A Pilot Randomized Controlled Trial
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.


Options:
A: Inclusion Criteria:

To be eligible to participate in the study, a patient must meet all of the following inclusion criteria:

* Patient is at least five years of age.
* Patient has been diagnosed with sickle cell anemia or sickle ß0-thalassemia (documented by hemoglobin electrophoresis).
* Patient has had at least two episodes of painful crises within 12 months of the screening visit.
* If the patient has been treated with an anti-sickling agent within three months of the screening visit, the therapy must have been continuous for at least three months with the intent to continue for the next 14 months.
* Patient or the patient's legally authorized representative has given written informed consent.
* If the patient is a female of child-bearing potential, she agrees to practice a recognized form of birth control during the course of the study.

Exclusion Criteria:

If the patient meets any of the following criteria, the patient must not be enrolled:

* Patient has a significant medical condition that required hospitalization (other than sickle painful crisis) within two months of the screening visit.
* Patient has diabetes mellitus with untreated fasting blood sugar \>115 mg/dL.
* Patient has prothrombin time International Normalized Ratio (INR) \> 2.0.
* Patient has serum albumin \< 3.0 g/dl.
* Patient has received any blood products within three weeks of the screening visit.
* Patient has a history of uncontrolled liver disease or renal insufficiency.
* Patient is pregnant or lactating.
* Patient has been treated with an experimental anti-sickling medication/treatment (except hydroxyurea) within 30 days of the screening visit.
* Patient has been treated with an experimental drug within 30 days of the screening visit.
* There are factors that would, in the judgment of the investigator, make it difficult for the patient to comply with the requirements of the study.
B: Inclusion Criteria:

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

Exclusion Criteria:

* 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
C: Inclusion Criteria:

* Individuals with SCD aged 2-19 y attending British Columbia Children's Hospital
* Individuals having received routine daily supplementation of folic acid for the prior 12-weeks

Exclusion Criteria:

* Individuals receiving a blood transfusion in the prior 12-weeks
* Individuals allergic to any components of the supplement (cellulose, methylcellulose, magnesium stearate, and/or titanium dioxide)
* Individuals presenting with megaloblastic anemia in the prior 12-weeks
* Individuals with pulmonary, renal and/or cardiac complications (severe or recurrent acute chest syndrome)
* Individuals routinely taking medications known to interfere with B vitamin metabolism (chloramphenicol, methotrexate, metformin, sulfasalazine, phenobarbital, primidone, triamterene, barbiturates)
* Individuals who are currently pregnant, planning to become pregnant in the next 9-months, or currently breastfeeding
* Individuals who have participated in a clinical research trial in the previous 30 days
* Individuals who have donated blood in the previous 30 days
* Individuals with unstable medical conditions or unstable laboratory results.
D: Inclusion Criteria:

1. Documented sickle cell anemia (HbSS supported by hemoglobin electrophoresis)
2. Age range of 1.00-4.99 years, inclusive, at the time of enrollment
3. Weight at least 5.0 kg at the time of enrollment
4. Willingness to comply with all study-related treatments, evaluations, and follow-up

Exclusion Criteria:

1. Known other chronic medical condition (e.g., HIV, malignancy, active clinical tuberculosis)
2. Severe malnutrition determined by impaired growth parameters as defined by the World Health Organization (WHO) (weight for length/height or height for age z-score \<-3, using WHO growth standards)

Answer: B