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
NCT ID: NCT03221816
Last Updated: 2017-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2008-12-31
2010-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluating the Impact of B Vitamin Supplementation (Soloways™) on Homocysteine and LDL-C Levels in Patients With MTHFR, MTR, and MTRR Polymorphisms.
NCT06163443
Effects of Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults
NCT06363565
The Effects of 8-week Choline, Betaine, and Folic Acid Supplementation on Plasma Homocysteine Concentration During Guanidinoacetic Acid Loading in Young Healthy Volunteers
NCT01371357
A Study to See if a Combination of Vitamins That is Injected Into a Muscle is as Good and Safe as a Vitamin That is Taken by Mouth
NCT07029698
Effects of Low-dose Complex B-vitamins on Homocysteine and Framingham Risk Score Among Chinese Elderly
NCT00755664
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo Oral Tablet
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.
Placebo Oral Tablet
Placebo group received the same tablet with the organoleptic characteristics of Tenavit® for a period of 4 months.
Experimental group (Tenavit®)
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.
Tenavit®
The experimental group received one tablet of Tenavit® daily for a period of 4 months.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
40 Years
79 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Casa de Saúde santa Marcelina
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Carolina Vicente Banzoli
Principal Investigator
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
Website of the Ministry of Health with mortality tables
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
U1111-1176-6998
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.