Effect of the N-acetylcysteine in the inmunologycal system
Phase 1
- Conditions
- Postmenopausal health woman aged more than 50 yearsTherapeutic area: Body processes [G] - Immune system processes [G12]
- Registration Number
- EUCTR2004-001098-25-ES
- Lead Sponsor
- Zambon SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 40
Inclusion Criteria
Postmenopausal women in good health more than 50 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
Exclusion Criteria
Women with a clinical condition or relevant analytical alterations
-Severe general condition
-Lymphacyte Proliferation values outside of the normal range for the age
-Immune diseases
-Cancer
-Dementia or cognitive alteration
-Chronic respiratory condition
-Arterial hypertension
-Diabetes
-Life expectancy < 1 year
-Low compliance level
-Continuous intake on N-acetylcysteine or vitamins or antioxidants in the previous six months
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluate the effect of N-Acetylcysteine on the inmmunitary system principally on the Linfocyte proliferation;Secondary Objective: Evaluate the effect of N-Acetylcysteine on:<br>- Lymphocytes: Adherence, movility, and production of IL2<br>- Neutrophyles:Adherence, movility, fagocytosis and superoxide anion production<br>- NK cells: Litic capacity<br>- Citoquines: TNF alfa production<br>To evaluate if the effect is maintained 3 months.;Primary end point(s): ?Changes in Lymphocyte Proliferation in each group of age.;Timepoint(s) of evaluation of this end point: 4 and 7 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Lymphocytes: Adherence, movility and production of IL2;Timepoint(s) of evaluation of this end point: 4 and 7 months