Health individuals - effects of folic acid excess.
Conditions
Interventions
Experimental group: 30 health individuals, both sex was submitted to an intervention with 1 tablet of 5 mg of folic acid / day was performed during 90 days.
Drug
V03.175.250
SP6.051.227
C15.378.071
Sponsors
Faculdade de Ciências Farmacêuticas da Universidade de São Paulo
Universidade Federal de São Paulo
Irmandade Santa Casa de Misericórdia de São Paulo
Eligibility
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Healthy subjects; both sexes; aged between 18 and 45 years.
Exclusion criteria
Exclusion criteria: Individuals under 18 years, chronic alcoholics; patients with acute or chronic diseases; pregnant women; users of immunosuppressive medications, vitamins or vitamin supplements; blood donors in the last six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected: Increase in serum concentrations of unmetabolized folic acid after 45 days and 90 days of daily use of 5mg folic acid, determined by microbiologic assay and by high performance liquid chromatography with mass spectrometry detection. ;Observed: Increased around 12 times the levels of serum unmetabolized folic acid after 45 days of intervention with 5 mg daily of folic acid. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected: Modifications in natural killer (NK) cell citotoxicity, after 45 days and 90 days of daily use of 5mg folic acid, determined by citotoxicity assay by flow cytometry.;Observado: in group 5, it was observed reduction in the number and cytotoxic activity of NK cells after the intervention period with folic acid." ;Expected: Unmetabolized folic acid levels are associated with intake of synthetic folic acid from fortified foods. The evaluation of folic acid intake from diet was determined by questionnaires: three 24h-recall and one of food frequency. ;Observed: Before intervention, it was observed correlation between intake of folic acid from fortificated food and unmetabolized folic acid levels. After the intervention this correlation was not observed. ;Expected:The serum concentrations of the cytokines interleukin-6, 8, 10 and tumoral factor alpha and interpheron gamma are affected by excess of folic acid.;Observed: The serum concentrations of cytokines studied were not affected by high serum concentration of folic acid after intervention period. The cytokines were determined in serum by multiplex assay. | — |
Countries
Brazil
Contacts
Public ContactElvira Guerra Shinohara
Faculdade de Ciências Farmacêuticas da Universidade de São Paulo
Outcome results
None listed