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
Condition: Menopause; Dyslipidemias; Homocystinaemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 4

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
    

Detailed description: 
      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).
    

Intervention name(s): Tenavit®; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): The experimental group received one tablet of Tenavit® daily for a period of 4 months.; Placebo group received the same tablet with the organoleptic characteristics of Tenavit® for a period of 4 months.
Other intervention name(s): pyridoxine, folic acid, cyanocobalamin; Placebo
Intervention MeSH terms: Folic Acid; Pyridoxine; Vitamin B 12
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Menopause; homocysteine; lipid profile