Zinc Supplement in ill persons with ataxia type SCA-2.

Drug Research and Development Center (CIDEM)0 个研究点目标入组 36 人开始时间: 2009年8月21日最近更新: 2024年8月19日

适应症

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研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

•Patients with ataxia type 2 (SCA-2) in in stages I-II -Age rank of participants from 18 to 60 inclusive, resident in Holguín -Subjects of both sexes -Liver and kidney functions among normal patterns -Not presenting dementia -Not to have ingested another medication during the 15 previous days neither having donated blood during the previous 3 months -With normal vital signs Systolic blood pressure *140 mm of Hg Diastolic blood pressure *90 mm of Hg Cardiac frequency 60-100 x min Respiratory frequency 16-20 x min -Complementary examinations of Hematology, HQ and urine within normal ranges established and declared in Section 13.1 of this protocol -Patients with CAG repetitions over 31 units -Written consent of patient

•-History of allergy, idiosyncrasy or hypersensitivity to the drug -Ingestion of alcohol during the 3 previous days -Individuals with alcoholism or drug addiction background -Patients with any neurological or systemic disorder affecting the nervous system -Patients with acute diseases at the moment of inclusion -Patients with decompensated chronic disorders associated to SCA-2 -Pregnancy or breastfeeding -Background or clinical evidence of the following pathologies: liver, heart, kidney, clotting or respiratory disorders, anemia or any other chronic disorders -Patients under treatment with immunosuppressive drugs -Any surgery performed during 6 months before the trial -Not meet any criteria for inclusión

发起方

Drug Research and Development Center (CIDEM)