CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 60 enrolled
Drug / intervention
Tenavit® +1 moredrug
Likely dose
Not stated in record
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Search/NCT03221816
NCT03221816Phase 4Completed

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

Casa de Saúde santa Marcelina·interventional·Posted Jul 19, 2017·Updated Jul 21, 2017

In Brief

A Phase 4 clinical trial evaluating Tenavit® and Placebo Oral Tablet for Menopause and 2 related conditions. Completed, enrolled 60 participants.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 19, 2017
Enrollment StartDec 1, 2008
Primary CompletionJan 1, 2010
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 9.0 years ago

Interventions

Tenavit®drug

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

Placebo Oral Tabletdrug

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