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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

NCT03221816 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-07-21

No results posted yet for this study

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

Conditions

Interventions

DRUG

Tenavit®

The experimental group received one tablet of Tenavit® daily for a period of 4 months.

DRUG

Placebo Oral Tablet

Placebo group received the same tablet with the organoleptic characteristics of Tenavit® for a period of 4 months.

Sponsors & Collaborators

  • Casa de Saúde santa Marcelina

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
79 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-01-31
Completion
2010-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03221816 on ClinicalTrials.gov