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 | Completed Phase 4

• 1 other identifier: U1111-1176-6998
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Menopause; Dyslipidemias; Homocystinaemia

Keywords

Menopause; homocysteine; lipid profile

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Placebo Oral Tablet

PLACEBO COMPARATOR

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

Experimental group (Tenavit®)

EXPERIMENTAL

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®

Interventions

Tenavit® DRUG

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

Also known as: pyridoxine, folic acid, cyanocobalamin

Experimental group (Tenavit®)

Placebo Oral Tablet DRUG

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

Also known as: Placebo

Placebo Oral Tablet

Eligibility Criteria

• Age: 40 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• women with one year of amenorrhea, FSH greater than 30, and those with dyslipidemia.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Casa de Saúde santa Marcelina: lead

Related Publications (12)

• Nair KG, Ashavaid TF, Nair SR, Eghlim FF. The genetic basis of hyperhomocysteinemia. Indian Heart J. 2000 Nov-Dec;52(7 Suppl):S16-17. No abstract available.

  PMID: 11339434 RESULT

• 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. doi: 10.1161/01.cir.99.9.1156.

  PMID: 10069782 RESULT

• 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. doi: 10.1001/jama.281.22.2113.

  PMID: 10367822 RESULT

• Fonseca V, Guba SC, Fink LM. Hyperhomocysteinemia and the endocrine system: implications for atherosclerosis and thrombosis. Endocr Rev. 1999 Oct;20(5):738-59. doi: 10.1210/edrv.20.5.0381. No abstract available.

  PMID: 10529901 RESULT

• 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. doi: 10.1093/ajcn/64.4.587.

  PMID: 8839504 RESULT

• 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. doi: 10.1001/jama.1993.03510220049033.

  PMID: 8133587 RESULT

• von Eckardstein A, Malinow MR, Upson B, Heinrich J, Schulte H, Schonfeld R, Kohler 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;14(3):460-4. doi: 10.1161/01.atv.14.3.460.

  PMID: 8123652 RESULT

• 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. doi: 10.1017/s0029665100000252.

  PMID: 10946791 RESULT

• 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 disentangling CVD into coronary heart disease (CHD) and stroke. Int J Cardiol. 2014 Feb 15;171(3):413-8. doi: 10.1016/j.ijcard.2013.12.036. Epub 2013 Dec 27.

  PMID: 24438922 RESULT

• Gokkusu C, Ozbek 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.

  PMID: 21877144 RESULT

• Reslan OM, Khalil RA. Vascular effects of estrogenic menopausal hormone therapy. Rev Recent Clin Trials. 2012 Feb;7(1):47-70. doi: 10.2174/157488712799363253.

  PMID: 21864249 RESULT

• 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. doi: 10.1373/clinchem.2007.097469. Epub 2007 Dec 10.

  PMID: 18070815 RESULT

Related Links

• Website of the Ministry of Health with mortality tables

MeSH Terms

Conditions

Dyslipidemias

Interventions

Pyridoxine; Folic Acid; Vitamin B 12

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Vitamin B 6; Picolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 19, 2017
• Study Start: December 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: May 1, 2010
• Last Updated: July 21, 2017

Record last verified: 2017-07