Ozone-Therapy-Immunoglobulin A deficiency-adults and childrens-Phase II

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.

Acronym of Public Title:

OTIGAD-2

Scientific title:

Systemic ozone therapy by means rectal insuflaction applied of the patiens with inmunoglobulin A deficency. (OTIGAD-2)

Acronym of Scientific Title:

OTIGAD-2

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Cuban ministry of Public Health (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:

Only approved by Ethics Committees

Principal investigator

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

First name:

Jacqueline

Last name:

Diaz Luis

Medical Specialty :

Second degree specialist in Immunology

Affiliation:

Roberto Rodriguez Fernandez general hospital

Postal address:

Zalla and Liberty Street

City:

Moron. Ciego de Avila province

Country:

Cuba

Zip Code:

67220

Telephone:

+53-33505986

+53-33505011 ext. 2413

Email address:

jdiaz@hgm.cav.sld.cu [1]

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:

Not applicable

Research ethics committees:

"Roberto Rodriguez Fernandez" General Hospital, January 5th, 2010

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

18/01/2010

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:

Immunoglobulin A Deficiency

Health condition(s) code:

IgA Deficiency

Dysgammaglobulinemia

Blood Protein Disorders

Hemic Diseases Hemic and Lymphatic Diseases

Immunologic Deficiency Syndromes

Immune System Diseases

Intervention(s):

Group 1 (experimental): Ozone Therapy + Covencional treatment ( antibiotics if infectious illnesses bacterial + especific meidication to control illnnesses associated to IgAD) . the ozone therapy is administred for the ractal manner, with a daily frecuency in cycle of 20 sessions, followed of three months sabbatical and next of 20 sessions with a daily frecuency. The management graduates of the following form: 1. childrens a)- elders of 4 years to 10 years ages: 1,2 mg - 3mg b)- from 11 to 15 years ages: 2,2 mg to 4,2 mg . 2- Childrens bigger 15 years and adults: 2mg-8mg. Group 2 ( Control ): Hebertrans +Covencional treatment ( antibiotics if infectious illnesses bacterial + especific meidication to control illnnesses associated to IgAD). the Hebertrans is utilized at the rate of 1 unit per square meter of the corporal surface, for the subcutaneous manner a week, during 12 weeks.

Intervention code:

Ozone

Complementary Therapies

Transfer Factor

Anti-Bacterial Agents

Insufflation

Administration, Rectal

Injections, Subcutaneous

Intervention keyword:

Hebertrans, Ozonotherapy

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):

Objective Response (Complete response, Partial response, Stable disease, Progressive disease). Measurement time: 2, 4 and 6 months.

Key secondary outcomes:

Immunoglobulin's levels-IgA, IgG, IgM (Normal, Enlarged, Diminished). Measurement time: at baseline, 4 and 6 months. Clinical State (Satisfactory, Acceptable, Equal). Measurement time: at baseline, 4 and 6 months. Oxidative-damage scoreboards (Normal, Enlarged, Diminished). Measurement time: at baseline and, 6 months. Antirust- defense scoreboards: at baseline and, 6 months. Adverse Events-AE (Occurrence of AE (Yes, No), Description of AE (name of the adverse event), Intensity of AE (Light, Moderated, Severe)). Measurement time: 2, 4 and 6 months. Illnesses associated (Occurrence of illnesses associated (Yes, No), Description of illness (Allergic, Autoimmune, Infectious)). Measurement time: at baseline.

Selection criterias

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

Gender:

Male/Female

Minimum age:

4 years

Maximum age:

50 years

Inclusion criteria:

1- IgA deficiency complete or partial, selective IgA deficiency or with deficient specific antibody response, IgAD isolated or associated to allergic , autoimmune and neoplasic illness. 2- Informed Consent of the parents for the participation of childrens in the study or Signed informed consent of the adults .

Exclusion criteria:

1- Having received blood transfusions three previous months or during the study 2- Having recived immunomodulator treatment 6 previous months to study. 3- Any specific conditions that advise against any one of the treatments.

Type of population:

Children and 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:

Open

Control group:

Active

Study design:

Parallel

Phase:

Target sample size:

inclusion for 6 years from january 18 , 2010

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:

Jacqueline

Last Name:

Diaz luis

Specialty:

Second degree specialist in Immunology

Affiliation:

Roberto Rodriguez Fernandez general hospital

Postal Address:

Zalla and Liberty street

City:

Moron. Ciego de Avila province

Country:

Cuba

Zip Code:

67220

Telephone:

+53-33505011

Email :

jdiaz@hgm.cav.sld.cu [1]

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:

Consuelo

Last Name:

Macías Abrahan

Specialty:

Second degree specialist in Immunology

Affiliation:

Hematology and Inmunology Institute

Postal Address:

San francisco and Perla, Altahabana

City:

Havana

Country:

Cuba

Zip Code:

10800

Telephone:

+537-6476135

Email :

cmacias@hemato.sld.cu [2]

jmballe@infomed.sld.cu [3]

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:

RPCEC00000236

Date of Registration in Primary Registry:

16/02/2017

Record Verification Date:

2017/02/16

Next update date:

2018/02/16

Link to the spanish version:

Click here [4]