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

Study Overview
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Brief Summary
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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

Detailed Description
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Subjects The study protocol and informed consent was approved by the Ethics Committee of the Hospital Santa Marcelina, Sao Paulo, Brazil (Process nº 09/08, CAAE nº 0016.0.270.000-08).Sixty women (figure 1) were postmenopausal selected from the outpatient Gynecology - Endocrine Hospital Santa Marcelina that passed by routine consultations and fulfilling the inclusion criteria were invited to the study. Inclusion criteria were: a year of amenorrhea, FSH (follicle stimulating hormone) greater than 30mUI/ml and submit dyslipidemia, defined as LDL> 150 mg / dl15. Women with diabetes difficult to control or with recent myocardial infarction or thromboembolic diseases, severe hepatic impairment or activity were excluded. In addition, patients who had any form of cancer were excluded from the group. Study Design The women were randomly allocated to control or experimental group (30 in each group) in a double-blind controlled clinical trial. The experimental group received one tablet of Tenavit®(pyridoxine hydrochloride 4.00mg + folic acid 0.80mg + cyanocobalamin 0.40mg) daily and the placebo group received the same tablet with the organoleptic characteristics of Tenavit® for a period of 4 months. After this period of treatment, the women were assessed. Procedures During clinical examination, a self-report questionnaire to assess quality of life (QSF-36) that demonstrates how the individual feels regarding your activities, your health and disposition on a daily, always referring to the last month15, was applied. The Framingham Score was also applied. Framingham predictions was good in the low- to intermediate cardiovascular risk16,17.Anthropometric measurements of blood pressure, weight, height, body mass index, waist and hip were evaluated by the same medical team. Venous blood was collected on two different occasions during the study (at baseline and at end of treatment), while maintaining the 12-hour fast and the interval of 4 months between tests, both in the experimental and in the control group. Total cholesterol and fractions, triglycerides, fasting glucose, homocysteine and cysteine were performed. The dosage of plasma homocysteine and cysteine was performed by high performance liquid chromatography (HPLC).

Official Title
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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

Conditions
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Menopause, Dyslipidemias, Homocystinaemia

Intervention / Treatment
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* Drug: Tenavit®
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo Oral Tablet<br>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 double-blind controlled clinical trial. The control group received the same tablet with the organoleptic characteristics of Tenavit® for a period of 4 months. | Drug: Placebo Oral Tablet<br>* Placebo group received the same tablet with the organoleptic characteristics of Tenavit® for a period of 4 months.<br>* Other names: Placebo;|
| Experimental: Experimental group (Tenavit®)<br>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 experimental group received one tablet of Tenavit® (pyridoxine hydrochloride 4.00mg + folic acid 0.80mg + cyanocobalamin 0.40 mg) daily and the placebo group received the same tablet with the organoleptic characteristics of Tenavit® for a period of 4 months. | Drug: Tenavit®<br>* The experimental group received one tablet of Tenavit® daily for a period of 4 months.<br>* Other names: pyridoxine, folic acid, cyanocobalamin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| supplementation may be beneficial in postmenopausal patients, with the intention to reduce the level of homocysteine | supplementation may be beneficial in postmenopausal patients, with the intention to reduce the level of homocysteine and, thus, reduce the cardiovascular risk in this age. | The women were assessed before the intervention and after 4 months of medication. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menopause, homocysteine, lipid profile