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

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000086
• Date of registration: 21/08/2009
• Primary sponsor: Drug Research and Development Center (CIDEM)
• Public title: Zinc Supplement in ill persons with ataxia type SCA-2.
• Scientific title: Zinc Supplement in ill persons with ataxia type SCA-2.
• Date of first enrolment: 14/07/2007
• Target sample size: 36
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000086-En
• Study type: Interventional
• Study design: Randomization: Randomized Controlled Trial Blinding: Double Blind Placebo: Placebo Assignment: Parallel Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Jorge E. Rodríguez Chanfrau
• Affiliation: Centro de Investigacion y Desarrollo de Medicamentos. (CIDEM)

• Name: Jorge E. Rodriguez Chanfrau
• Affiliation: Centro de Investigacion y Desarrollo de Medicamentos (CIDEM)

Key inclusion & exclusion criteria

Inclusion criteria: -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
Exclusion criteria: -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

Age minimum: 18 years
Age maximum: 60 years
Gender: Both

Health Condition(s) or Problem(s) studied

Ataxia type SCA-2

Intervention(s)

Group I (Study group). Rehabilitation + Zinc. Physical rehabilitation program and 1 daily dose of Zinc 50 mg orally. Treatment duration: 6 months. Group II (Control group). Rehabilitation + Placebo. Physical rehabilitation program as well as group I, and 1 daily dose of placebo 50 mg orally. Treatment duration: 6 months.

Primary Outcome(s)

Total zinc content of blood serum (mmol/L), Measurement time: at baseline, 3 months after treatment and 6 months after treatment.

Secondary Outcome(s)

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.

Secondary ID(s)

EC-04001

Source(s) of Monetary Support

Public Health Ministery of Cuba (MINSAP)