Oral Magnesium Pidolate, Hemoglobin SC Disease, MG Pidolate
HEMOGLOBIN SC DISEASE
About this trial
This is an interventional treatment trial for HEMOGLOBIN SC DISEASE focused on measuring Hemoglobin SC disease, sickle cell-hemoglobin
Eligibility Criteria
Inclusion criteria: This protocol is open to male and female patients of all races with a diagnosis of severe sickle hemoglobinopathy providing they also satisfy the following eligibility criteria: Adult and pediatric patients with Hb SC disease who are able to swallow the Mg pidolate preparation and who have had at least one prior painful crisis. Exclusion Criteria: Patients transfused within 90 days of study entry, Patients with elevated (>1.5 times upper limit of normal for age) BUN, creatinine, or liver function tests > 3 times the upper limit of normal for age, Patients who take a magnesium-containing medication (Mylanta, Maalox, etc.) on a regular (i.e., more than 2 days per week) basis. Patients with progressive neuromuscular disease or patients who are treated with a calcium channel blocker. Pregnancy
Sites / Locations
- Children's Hospital
- Texas Children's Hospital
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
Placebo
MG Pidolate Administration
A computer-generated randomization list will be created by a Baylor College of Medicine statistician (unrelated to study) prior to the study. Patients are randomly assigned to either start with Mg pidolate or placebo and will continue that therapy for 24 weeks. Then, after a 2 month wash-out period, they will be switched to the other arm and continue on that arm for another 24 weeks, followed by 8 weeks of observation off study drug. Both patient and medical care provider(s) will be blinded to treatment assignment. Mg pidolate and placebo will be distributed through the pharmacy with labels that do not indicate the assignment.
A computer-generated randomization list will be created by a Baylor College of Medicine statistician (unrelated to study) prior to the study. Patients are randomly assigned to either start with Mg pidolate or placebo and will continue that therapy for 24 weeks. Then, after a 2 month wash-out period, they will be switched to the other arm and continue on that arm for another 24 weeks, followed by 8 weeks of observation off study drug. Both patient and medical care provider(s) will be blinded to treatment assignment. Mg pidolate and placebo will be distributed through the pharmacy with labels that do not indicate the assignment.