healthy individuals
Conditions
Interventions
Two groups of individuals are being studied:
Group 1 - Non-pregnant women who have a history of recurrent miscarriage and take folic acid. 40 women will be included with at least two consecutive spont
Second collection to be performed after 18 to 20 weeks
(Median of 133 days) and third collection to be performed after 28 to 30 weeks (median
203 days). Patients will be recruited at the Obstetrics Cl
vitamin B12 and holotranscobalamin
concentrations of total homocysteine, vitamin B6 and unmetabolized folic acid by LC-MS. Also, determination of the minerals iron, copper, zinc and selenium and oxidative stress biomarkers.
Group 2 -
Drug
V03.175.250
SP6.051.227
Sponsors
CNPq - Conselho Nacional de Desenvolvimento Científico e Tecnológico
Faculdade de Ciências Farmacêuticas da Universidade de São Paulo
FAPESP - Fundação de Amparo à Pesquisa do Estado de São Paulo
Eligibility
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: For the group of non-pregnant women with a history of primary miscarriage: women aged 18-40 years; at least two histories of recurrent spontaneous miscarriage; no viable fetus; in use of 5 mg of folic acid daily. For the prospective study with intervention of 5 mg of folic acid per day: healthy volunteers; both sexes, from 18 to 45 years, non smokers.
Exclusion criteria
Exclusion criteria: Women with a history of abortion who are pregnant during study enrollment. For the study with intervention of 5 mg of folic acid per day will be excluded chronic alcoholics; patients with chronic diseases; pregnant women; smokers; individuals who underwent major surgery to less than 6 months or donated blood in the last 3 months; and Those who have used polivitamins in the last 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of folic acid at high concentrations on dihydrofolate reductase (DHFR) enzyme activity and its relation to the mRNA expression of related genes of folate metabolism (DHFR, MTHFR) and inflammatory cytokines in women with recurrent history of s pontaneous miscarriage and in healthy subjects taking a daily dose of 5 mg of folic acid.It will be collected fasting blood in the different periods of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the concentrations of folic acid and to verify if there is an association betweem the supraphysiological concentrations of this vitamin with DHFR enzyme activity.It will be collected fasting blood in the different periods of the study. Serum folic acid will be determine by microbiologic assay and the enzyme's activity by spectrophotometry. ;To verify if high doses of folic acid interfere with the metabolism of copper, zinc and selenium, and also in oxidative stress biomarkers. It will be collected fasting blood in the different periods of the study. Serum folic acid will be determine by microbiologic assay, minerals by spectrophotometry and oxidative stress biomarkers by automated assays. ;To verify the effects of high doses of folic acid in others vitamins from complex B and possible alterations in cytokines leves (RNA m expression and serum). It will be collected fasting blood in the different periods of the study. Serum folic acid and vitamin B12 will be determine by microbiologic assay and The cytokines in serum by multiplex assay.;To assess the dietary intake of the groups of this study, in order to determine the intake of total folate, food folate and folic acid from fortified foods. It will be collected 2 24-hours-recalls in each period of the study, which will be later calculated using the software Nutrition Data System for Research - NDSR (University of Minnesota, Minneapolis,USA. | — |
Countries
Brazil
Contacts
Public ContactCecilia;Elvira Zanin Palchetti;Guerra Shinohara
Faculdade de Ciências Farmacêuticas da Universidade de São Paulo;Faculdade de Ciências Farmacêuticas da Universidade de São Paulo
Outcome results
None listed