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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00532883
Recruitment Status : Terminated (Enrollment has been terminated due to a slow rate of enrollment.)
First Posted : September 21, 2007
Results First Posted : May 11, 2010
Last Update Posted : January 18, 2013
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hemoglobin SC Disease Drug: Hydroxyurea Drug: Magnesium Pidolate Other: Placebo Pills and Placebo Liquid Phase 2

Detailed Description:

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 pills once a day and the magnesium pidolate or placebo liquid twice a day for 11 months. Study visits will occur every 2 weeks during the first 2 months of the study, once a month for the following 9 months, and then at Year 1. At each visit, a physical exam and blood collection will occur. Selected visits will also include urine collection and a pregnancy test for female participants. Throughout the study, participants will record their study medication use in a daily diary.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Hydroxyurea and Magnesium Pidolate Alone and in Combination in Hemoglobin SC Disease: A Phase II Trial
Study Start Date : January 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Pills and Placebo Liquid Other: Placebo Pills and Placebo Liquid
HU/Placebo capsules (20 mg/kg/day for 11 months) Mg/Placebo liquid (0.6 mEq/kg/day for 11 months)
Active Comparator: Hydroxyurea Pills and Placebo Liquid Drug: Hydroxyurea
HU capsules (20 mg/kg/day for 11 months) Mg/Placebo liquid (0.6 mEq/kg/day for 11 months)
Active Comparator: Placebo Pills and Magnesium Pidolate Liquid Drug: Magnesium Pidolate
HU/Placebo capsules (20 mg/kg/day for 11 months) Mg liquid (0.6 mEq/kg/day for 11 months)
Active Comparator: Hydroxyurea Pills and Magnesium Pidolate Liquid Drug: Hydroxyurea
HU capsules (20 mg/kg/day for 11 months) Mg/Placebo liquid (0.6 mEq/kg/day for 11 months)

Drug: Magnesium Pidolate
HU/Placebo capsules (20 mg/kg/day for 11 months) Mg liquid (0.6 mEq/kg/day for 11 months)


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of HbSC disease
  • Hemoglobin level between 8 and 12.5 g/dL
  • At least one vaso-occlusive event (e.g., pain, acute chest syndrome) in the 12 months prior to study entry. An episode of pain is defined as the occurrence of pain in the extremities, back, abdomen, chest, or head that lasts at least 2 hours; requires a visit to a hospital, emergency room, clinic, or provider's office; and is not explained except by SCD. Acute chest syndrome is defined as a new pulmonary infiltrate on a chest x-ray associated with a fever (greater than 38.5° C), tachypnea, wheezing, cough, or chest pain.
  • Regular compliance with comprehensive care
  • In a steady disease state and not experiencing an acute complication of SCD (i.e., no hospitalization, pain event, or episode of acute chest syndrome within the 1 month prior to study entry)

Exclusion Criteria:

  • Previous transfusion with remaining hemoglobin A greater than 10%
  • Previous treatment with hydroxyurea within the last 3 months
  • Previous treatment with magnesium within the 3 months prior to study entry (including vitamins containing magnesium)
  • Poor compliance with previous treatment regimens
  • Liver dysfunction (SGPT greater than twice the upper limit of normal) within the 1 month prior to study entry
  • Kidney dysfunction (creatinine greater than or equal to 1.0 mg/dL for participants less than 18 years of age; greater than or equal to 1.2 mg/dL for participants 18 years of age or older) within the 1 month prior to study entry
  • Pregnant
  • Ten or more hospital admissions for pain in the 12 months prior to study entry
  • Daily use of narcotics
  • Treatment with any investigational drug in the 3 months prior to study entry
  • Less than 3% red blood cells with density greater than 41 g/dL (as measured by the ADVIA 120 system)
  • Positive HIV test
  • Other long-term illness or disorder other than SCD that could adversely affect performance in the study (e.g., tuberculosis)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532883


Locations
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Sponsors and Collaborators
St. Jude Children's Research Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Winfred C. Wang, MD St. Jude Children's Research Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00532883    
Other Study ID Numbers: CHAMPS-St. Jude
U54HL070587 ( U.S. NIH Grant/Contract )
First Posted: September 21, 2007    Key Record Dates
Results First Posted: May 11, 2010
Last Update Posted: January 18, 2013
Last Verified: January 2010
Keywords provided by St. Jude Children's Research Hospital:
Sickle Cell Disease
Vaso-occlusive Event
Painful Crises
Acute Chest Syndrome
Additional relevant MeSH terms:
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Hemoglobin SC Disease
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
 Genetic Diseases, Inborn
Hydroxyurea
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors