Effect of Polyvitaminics (Pyridoxine Hydrochloride, Folic Acid and Cyanocobalamin) in the Concentration of Homocysteine and Lipid Profile in Postmenopausal Women: a Randomized Controlled, Double-blind Clinical Trial

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

Introduction: Cardiovascular diseases (CVD) are the main cause of death in Western countries. High levels of homocysteine (He) has been considered an important risk factor for coronary artery disease. Objective: To evaluate the effects of the drug Tenavit® (pyridoxine hydrochloride 4.00mg + folic acid 0.80mg + cyanocobalamin 0.40 mg) on plasma homocysteine concentrations and lipid profile in postmenopausal women. Methods: Sixty women were postmenopausal selected from the outpatient Gynecology Hospital Santa Marcelina that passed by routine consultations and fulfilling the inclusion criteria were invited to the study. The women were randomly allocated to control or experimental group (30 in each group) in a do uble-blind controlled clinical trial. The experimental group received one tablet of Tenavit® daily and the placebo group received the same tablet with the organoleptic characteristics of Tenavit® for a period of 4 months. The women were assessed before the intervention and after 4 months of medication. A self-report questionnaire to assess quality of life (QSF-36) was applied and anthropometric measurements, cholesterol and fractions, triglycerides, fasting glucose, homocysteine and cysteine were evaluated. Results: The only variable that presented significant alteration in both dimensions (between and within group) was the homocysteine. It was observed statistical significant between groups in the final measure for homocysteine (control group: 11.5mmol/ L; experimental group: 9.4 mmo

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Casa de Saúde santa Marcelina
• Treatments: Folic Acid; Hydroxocobalamin; Pyridoxal; Pyridoxine; Vitamin B 12; Vitamin B 6; Vitamin B Complex

Criteria

Inclusion Criteria:

• 60 women with one year of amenorrhea, FSH greater than 30, and those with dyslipidemia.

Exclusion Criteria:

• Women with difficult-to-control diabetes, recent heart attack or thromboembolic diseases, severe or active hepatic failure were excluded from this group. In addition, patients who had cancer.