Healthy volunteers
Conditions
Interventions
Experimental group: 80 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
Sponsors
Faculdade de Ciências Farmacêuticas da Universidade de São Paulo
Faculdade de Ciências Farmacêuticas da Universidade 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 immunossupressive medications, vitamins or vitamin supplements; blood donors in the last six months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EXPECTED OUTCOME 1. It is expected to find serum vitamin B6 concentrations decrease after use of 5 mg / day of folic acid, determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS);OBSERVED OUTICOME 1. Serum concentrations of vitamin B6 forms, pyridoxal 5'-phosphate, pyridoxal and 4-pyridoxic acid were assessed by LC-MS/MS in individuals after and before 45 and 90 days of 5 mg folic acid use. A 12.8% increase in serum pyridoxal concentrations was observed after 45 days and 16.0% after 90 days of daily intervention with 5 mg of folic acid;EXPECTED OUTCOME 2. It is expected to find serum vitamin B2 concentrations decrease after use of 5 mg / day of folic acid, determined by liquid chromatography-tandem mass spectrometry (LC-MS/MS);OBSERVED OUTCOME 2. Serum concentrations of vitamin B2, riboflavin and flavon mononucleotide forms were evaluated by the LC-MS / MS method of individuals before and after 45 and 90 days of use of 5 mg of folic acid. Serum riboflavin and flavin mononucleotide concentrations increased by 11.6% and 12.6%, respectively, after 45 days, and 10.9% and 14.3%, respectively, after 90 days of daily intervention with 5 mg. of folic acid | — |
Secondary
| Measure | Time frame |
|---|---|
| EXPECTED OUTCOME 3: A change in the profile of tryptophan serum metabolite concentrations is expected in subjects following the use of 5 mg / day of folic acid as determined by LC-MS / MS.;OBSERVED OUTCOME 3: A 15.2% and 24.1% increase was observed only in serum anthranilic acid (tryptophan metabolite) concentrations after 45 and 90 days of daily folic acid intervention, respectively, as assessed by LC-MS / MS.;EXPECTED OUTCOME 4: It is expected a change in the number of T, B and NK cells in individuals after use of 5 mg / day of folic acid, determined by flow cytometry after labeling with antibodies specific for each cell line;OBSERVED OUTCOME 4: We observed increased number of CD4 + T lymphocytes and decrease of CD8 + T lymphocytes of individuals after 90 days of use of 5 mg / day of folic acid, evaluated by flow cytometry after labeling with specific antibodies for each cell line;EXPECTED OUTCOME 5: A reduction in the number of regulatory T cells (activated by PMA and ionomycin and without stimulation) is expected from individuals following the use of 5 mg/day of folic acid, determined by flow cytometry;OBSERVED OUTCOME 5: A decrease on number of regulatory T cells stimulated by PMA and ionomycin was observed after 90 days of daily intervention with 5 mg of folic acid, determined by flow cytometry;EXPECTED OUTCOME 6: It is expected a change in mRNA expression of genes of inflammatory cytokine in mononuclear leukocytes of individuals after use of 5 mg/day of folic acid, determined by the real-time polymerase chain reaction (RT- PCR);OBSERVED OUTCOME 6: A 78% and 64% increase in tumor necrosis factor mRNA gene expression was observed in mononuclear cells of individuals submitted to 45 and 90 days, respectively, of daily intervention with 5 mg of folic acid, evaluated by RT-PCR | — |
Countries
Brazil
Contacts
Public ContactElvira Guerra Shinohara
Faculdade de Ciências Farmacêuticas da Universidade de São Paulo
Outcome results
None listed