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

This study has been completed.

First Received on June 26, 2002. Last Updated on April 9, 2007 History of Changes

Sponsor:	Baylor College of Medicine
Collaborators:	Texas Children's Hospital Children's Hospital Boston
Information provided by:	Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00040456

Purpose

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.

Condition	Intervention	Phase
Hemoglobin SC Disease	Drug: Mg Pidolate	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	The Effect of Oral Magnesium Pidolate on Incidence of Painful Crises in Patients With Hemoglobin SC Disease

Resource links provided by NLM:

Genetics Home Reference related topics: sickle cell disease

Drug Information available for: Pyrrolidonecarboxylic acid Magnesium pidolate Magnesium

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Estimated Enrollment:	20
Study Start Date:	March 2000
Estimated Study Completion Date:	May 2005

Detailed Description:

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040456

Locations

United States, Massachusetts
Children's Hospital
Boston, Massachusetts, United States, 02115
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor College of Medicine

Texas Children's Hospital

Children's Hospital Boston

Investigators

Study Chair:

Brigitta Mueller, MD

Baylor College of Medicine

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00040456 History of Changes
Other Study ID Numbers:	H9251, MG Pidolate
Study First Received:	June 26, 2002
Last Updated:	April 9, 2007
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hemoglobin SC Disease
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic

Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on February 09, 2012