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

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03221816
• Other study ID #: U1111-1176-6998
• Status: Completed
• Phase: Phase 4
• First received: July 17, 2017
• Last updated: July 18, 2017
• Start date: December 2008
• Est. completion date: May 2010

Study information

• Verified date: July 2017
• Source: Casa de Saúde santa Marcelina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias
• Homocystinaemia
• Menopause

Intervention

Drug:
• Tenavit®
The experimental group received one tablet of Tenavit® daily for a period of 4 months.
• Placebo Oral Tablet
Placebo group received the same tablet with the organoleptic characteristics of Tenavit® for a period of 4 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Casa de Saúde santa Marcelina

References & Publications (12)

Chambers JC, McGregor A, Jean-Marie J, Obeid OA, Kooner JS. Demonstration of rapid onset vascular endothelial dysfunction after hyperhomocysteinemia: an effect reversible with vitamin C therapy. Circulation. 1999 Mar 9;99(9):1156-60. — View Citation

Dodds L, Fell DB, Dooley KC, Armson BA, Allen AC, Nassar BA, Perkins S, Joseph KS. Effect of homocysteine concentration in early pregnancy on gestational hypertensive disorders and other pregnancy outcomes. Clin Chem. 2008 Feb;54(2):326-34. Epub 2007 Dec — View Citation

Fonseca V, Guba SC, Fink LM. Hyperhomocysteinemia and the endocrine system: implications for atherosclerosis and thrombosis. Endocr Rev. 1999 Oct;20(5):738-59. Review. — View Citation

Gökkusu C, Özbek Z, Tata G. Hormone replacement therapy: relation to homocysteine and prooxidant-antioxidant status in healthy postmenopausal women. Arch Gynecol Obstet. 2012 Mar;285(3):733-9. doi: 10.1007/s00404-011-2051-2. Epub 2011 Aug 30. — View Citation

Lussier-Cacan S, Xhignesse M, Piolot A, Selhub J, Davignon J, Genest J Jr. Plasma total homocysteine in healthy subjects: sex-specific relation with biological traits. Am J Clin Nutr. 1996 Oct;64(4):587-93. — View Citation

McKinley MC. Nutritional aspects and possible pathological mechanisms of hyperhomocysteinaemia: an independent risk factor for vascular disease. Proc Nutr Soc. 2000 May;59(2):221-37. Review. — View Citation

Nair KG, Ashavaid TF, Nair SR, Eghlim FF. The genetic basis of hyperhomocysteinemia. Indian Heart J. 2000 Nov-Dec;52(7 Suppl):S16-17. Review. — View Citation

Nappo F, De Rosa N, Marfella R, De Lucia D, Ingrosso D, Perna AF, Farzati B, Giugliano D. Impairment of endothelial functions by acute hyperhomocysteinemia and reversal by antioxidant vitamins. JAMA. 1999 Jun 9;281(22):2113-8. — View Citation

Reslan OM, Khalil RA. Vascular effects of estrogenic menopausal hormone therapy. Rev Recent Clin Trials. 2012 Feb;7(1):47-70. Review. — View Citation

Selhub J, Jacques PF, Wilson PW, Rush D, Rosenberg IH. Vitamin status and intake as primary determinants of homocysteinemia in an elderly population. JAMA. 1993 Dec 8;270(22):2693-8. — View Citation

van Kempen BJ, Ferket BS, Kavousi M, Leening MJ, Steyerberg EW, Ikram MA, Witteman JC, Hofman A, Franco OH, Hunink MG. Performance of Framingham cardiovascular disease (CVD) predictions in the Rotterdam Study taking into account competing risks and disent — View Citation

von Eckardstein A, Malinow MR, Upson B, Heinrich J, Schulte H, Schönfeld R, Köhler E, Assmann G. Effects of age, lipoproteins, and hemostatic parameters on the role of homocyst(e)inemia as a cardiovascular risk factor in men. Arterioscler Thromb. 1994 Mar — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   Website of the Ministry of Health with mortality tables