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

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Secondary indentifying numbers:

EC-04001

Issuing authority of the secondary identifying numbers:

Drug Research and Development Center (CIDEM)

Source(s) of monetary or material support:

Public Health Ministery of Cuba (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

20/06/2007

Reference number:

1149/06.008.07

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Dr Luis Velazquez Pérez

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

País:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

None

Research ethics committees:

CIRAH, April 20 2005

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

14/07/2007

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

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.

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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

Key secondary outcomes:

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.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

60 years

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

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2

Target sample size:

36

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Jorge E.

Last Name:

Rodríguez Chanfrau

Affiliation:

Centro de Investigacion y Desarrollo de Medicamentos. (CIDEM)

Postal Address:

Ave 26 # 1605. Nuevo Vedado. Ciudad de la Habana.

City:

Ciudad de la Habana

País:

Cuba

Zip Code:

10600

Telephone:

Ciudad de la Habana. 5378810892

Email :

jorge@cidem.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Jorge E.

Last Name:

Rodriguez Chanfrau

Affiliation:

Centro de Investigacion y Desarrollo de Medicamentos (CIDEM)

Postal Address:

Ave 26 # 1605. Nuevo Vedado. Ciudad de la Habana. Cuba

City:

Ciudad de la Habana

País:

Cuba

Zip Code:

10600

Telephone:

5378810892

Email :

jorge@cidem.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000086

Date of Registration in Primary Registry:

2009-08-21

Record Verification Date:

2009-08-05 20:00

Link to the spanish version:

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Ensayos Registrados

Proceso de Registro

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

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