Zinc Supplement in ill persons with ataxia type SCA-2.
- Conditions
- Ataxia type SCA-2
- Registration Number
- RPCEC00000086
- Lead Sponsor
- Drug Research and Development Center (CIDEM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 36
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total zinc content of blood serum (mmol/L), Measurement time: at baseline, 3 months after treatment and 6 months after treatment.
- Secondary Outcome Measures
Name Time Method Total content of iron and copper in blood serum (mmol/L), measuring time: at baseline, 3 months after treatment and 6 months after treatment. Total content of zinc, iron and copper in cerebrospinal fluid(CSF) (mg/L), measuring time: at baseline, and 6 months after treatment. Values SOD, CAT, GST, TBARS, GSH, and Cu-Zn SOD in blood serum, measurement time: at baseline, 3 months after treatment and 6 months after treatment Values SOD, CAT, GST, TBARS, GSH, and Cu-Zn SOD in cerebrospinal fluid(CSF) Measurement time: at baseline and 3 months after treatment. Electrophysiological and neurocognitive variables, measurement time: at baseline, 3 months after treatment and 6 months after treatment. Adverse events, measuring time: 3 months after treatment and 6 months after treatment.