Clinical Trial: Hydroxyurea and Magnesium Pidolate to Treat People With Hemoglobin Sickle Cell Disease

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Effectiveness of Hydroxyurea and Magnesium Pidolate Alone and in Combination in Hemoglobin SC Disease: A Phase II Trial

Brief Summary: Sickle cell disease (SCD), also known as sickle cell anemia, is an inherited blood disease that can cause intense pain episodes. Hemoglobin SCD (HbSC) is a form of SCD that is characterized by dense red blood cells. The purpose of this study is to evaluate the safety and effectiveness of hydroxyurea and magnesium pidolate, alone and combined, at reducing red blood cell density and the frequency of pain episodes in people with HbSC.

Detailed Summary:

SCD is an inherited blood disorder. Symptoms include anemia, infections, organ damage, and intense episodes of pain, which are called "sickle cell crises." SCD is caused by an abnormal type of hemoglobin, which is a protein inside red blood cells that carries oxygen. HbSC is a form of SCD that is characterized by the presence of dense red blood cells. People with HbSC usually develop less severe SCD symptoms than people with the more common form of the disease. There are limited treatment approaches aimed specifically at modifying the abnormal state of red blood cells. Also, few combination therapy treatments have been studied. The medication hydroxyurea is currently used to prevent sickle cell crises and to decrease the need for blood transfusions. The dietary supplement magnesium has not been widely studied as a treatment for SCD, but it may prevent dehydration, which may decrease the frequency of sickle cell crises. The purpose of this study is to evaluate the safety and effectiveness of hydroxyurea and magnesium pidolate, alone and combined, at reducing red blood cell density and the frequency of sickle cell crises in people with HbSC.

This 1-year study will enroll people with HbSC. Participants will be randomly assigned to one of the following four treatment groups:

  • Group 1 participants will receive placebo pills and placebo liquid.
  • Group 2 participants will receive hydroxyurea pills and placebo liquid.
  • Group 3 participants will receive placebo pills and magnesium pidolate liquid.
  • Group 4 participants will receive hydroxyurea pills and magnesium pidolate liquid.

Participants will receive the hydroxyurea or placebo pil
Sponsor: St. Jude Children's Research Hospital

Current Primary Outcome: Distribution of the Density of Hemoglobin SC Red Cells [ Time Frame: measured 2 months after initiation of treatment ]

An individuals' percentage of red blood cells with density greater than 41 g/dL as measured by Advia.


Original Primary Outcome: Density of hemoglobin sickle cell red cells (percent of red blood cells with density greater than 41 g/dL) [ Time Frame: Measured at Month 2 ]

Current Secondary Outcome:

Original Secondary Outcome:

  • Standard hematologic parameters, including hemoglobin level, mean cell volume (MCV), reticulocyte count, white blood cell count, platelet count, and absolute neutrophil count (ANC) [ Time Frame: Measured at Year 1 ]
  • Hemoglobin S, C, and F levels [ Time Frame: Measured at Year 1 ]
  • Red cell metabolic studies, including potassium chloride (K-Cl) co-transport activity, Gardos channel activity, sodium-magnesium (Na-Mg) exchanger activity, red cell cation content, and intracellular Mg [ Time Frame: Measured at Year 1 ]
  • Plasma total Mg and ionized Mg (iMg) levels [ Time Frame: Measured at Year 1 ]
  • Adhesion studies to laminin, thrombospondin, and endothelial cells; expression of red blood cell receptors and phosphatidylserine; and adhesive response to epinephrine [ Time Frame: Measured at Year 1 ]
  • Frequency of clinical vaso-occlusive events (e.g., pain events, acute chest syndrome) [ Time Frame: Measured at Year 1 ]


Information By: St. Jude Children's Research Hospital

Dates:
Date Received: September 20, 2007
Date Started: January 2007
Date Completion:
Last Updated: January 14, 2013
Last Verified: January 2010