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The Effect of Oral Magnesium Pidolate on How Often Painful Crises Happens in Patients with Hemoglobin SC Disease



The Effect of Oral Magnesium Pidolate on How Often Painful Crises Happens in Patients with Hemoglobin SC Disease

For Condition: Hemoglobin SC Disease
Status: Recruiting
Sponsor(s): Baylor College of Medicine , Texas Children's Hospital,Children's Hospital Boston
Synopsis: The purpose of this study is to find out whether treatment with magnesium pidolate will increase the amount of water in the red blood cell and result in fewer painful crises in patients with hemoglobin SC disease while not causing diarrhea.
Details: Patients will be randomly assigned to study medication (Mg pidolate or placebo) for 24 weeks, followed by a washout period of 8 weeks. After the washout period each patient will receive a further 24 weeks of study medication.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 20

Location and Contact Information:

Overall Study Official:
BrigittaMueller,  Study Chair,  Baylor College of Medicine

Children's Hospital *Recruiting*
Boston,  Massachusetts,  02115
United States
Recruiting Elizabeth  Mullen 617-632-5291

Texas Children's Hospital *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Brigitta  Mueller 832-824-4277


Additional Information:
Study ID Numbers:
  H9251;  MG Pidolate
Study Start Date: March 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00040456

Other Hemoglobin Sc Disease Studies:
1. The Effect of Oral Magnesium Pidolate on How Often Painful Crises Happens in Patients with Hemoglobin SC Disease

2. A Phase I/II Trial of Recombinant-Methionyl Human Stem Cell Factor (SCF) in Adult Patients with Sickling Disorders

3. Stem Cell Transplantation after Reduced-Dose Chemotherapy for Patients with Sickle Cell Disease or Thalassemia

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The Effect of Oral Magnesium Pidolate on How Often Painful Crises Happens in Patients with Hemoglobin SC Disease

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