Hydroxyurea and Magnesium Pidolate to Treat People With Hemoglobin Sickle Cell Disease
Condition: Hemoglobin SC Disease
MeSH terms: Hemoglobin SC Disease
Intervention: Hydroxyurea; Magnesium Pidolate; Placebo Pills and Placebo Liquid
Intervention description: HU capsules (20 mg/kg/day for 11 months) Mg/Placebo liquid (0.6 mEq/kg/day for 11 months); HU/Placebo capsules (20 mg/kg/day for 11 months) Mg liquid (0.6 mEq/kg/day for 11 months); HU/Placebo capsules (20 mg/kg/day for 11 months) Mg/Placebo liquid (0.6 mEq/kg/day for 11 months)
Intervention MeSH terms: Hydroxyurea
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 44.0
Sex: All
Minimum age: 5 Years
Healthy volunteers: No
Keywords: Sickle Cell Disease; Vaso-occlusive Event; Painful Crises; Acute Chest Syndrome

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.
    

Eligibility 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)