This study is conducted in women postmenopausal
Conditions
Interventions
Clinical trial, double-blind, placebo-controlled, randomized to evaluate the effect of vitamin D supplementation (1000IU/day) and cross-sectional study. The population group will consist of patients t
Dietary supplement
D04.808.812.768
Sponsors
Faculdade de Medicina de Botucatu - UNESP
Fundação de Amparo a Pesquisa do Estado de São Paulo - FAPESP
Eligibility
Sex/Gender
Female
Age
45 Years to No maximum
Inclusion criteria
Inclusion criteria: Last menstrual period for at least 12 months, age greater than or equal to 45 years old who accept participate and vitamin D deficiency
Exclusion criteria
Exclusion criteria: DAC manifest presence of current or past; Cerebrovascular arterial disease; aneurysmal disease; peripheral arterial disease; chronic kidney disease; insulin dependent diabetes; liver disease; autoimmune diseases; alcoholic or drogaditas; use of pharmacological doses of VD
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A double-blind, placebo-controlled study of postmenopausal women. The sample size calculation is based on the literature demonstrating a 31% reduction in the mean IL-6 levels after VitD supplementation (6.5 vs 4.4 pg / mL). Correcting the estimates for type I (5%) and type II (20%) errors attributed to the study, the sample size estimate was 60 women per group. Considering a loss of follow-up of 20%, the sample size adopted was 80 women per group. It is expected to find high plasma concentrations of 25 [25 (OH) D] hydroxyvitamin D in the group supplemented with hydroxyvitamin D. Using the high performance liquid chromatography (HPLC) method. In the group supplemented with hydroxyvitamin D, differences in the serum concentrations of cytokines: interleukins (ILs) -1beta, IL-6, IL-10, IL-17, tumor necrosis factor alpha (TNF-alpha) and interferon-gamma (IFN-gamma) are determined by the Elisa immunoassay method.;After 10 months of administration using the HPLC method, mean values of vitamin D increased significantly in the VitD group (+ 45.4%, P <0.001) and a decrease (-18.5%, P = 0.049) in the placebo group . After 10 months of administration using the Elisa immune-assay method, the group of women supplemented with vitamin D showed a significant reduction of IL-17 (-57.1%), TNF-alpha (-24.1%) and IFN (-47.0%), IL-6 (1.3 ± 2.5 pg / mL versus 2.0 ± 3.6 pg / mL) with lower endpoints for the vitamin D group compared to the group placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| outcome outcome 2 It is expected to find after 10 months of administration, using Elisa's technique for altering serum levels of IL-1 or IL-10 in both groups. To assess the rate of adherence to the study, with no differences between treatment groups (vitamin D or placebo);Outcome found 2 After 10 months of administration using the ELISA method, mean serum levels of IL-1 or IL-10 did not show significant differences after the intervention period in both groups. The adherence rate was 92% for the study, with no differences between treatment groups (vitamin D or placebo).;Expected outcome 3 It is expected to find high levels of HSPs (27, 27 (total), 60, 70/72, 90a using serological samples and multiplex immunoassay technique after 10 months of administration of hydroxyvitamin D and placebo group.;Outcome found 3 After 10 months of administration of hydroxyvitamin D and placebo group of postmenopausal women with women with metabolic syndrome verified by the multiplex immunoassay technique, serum levels of HSP27 (total) and HSP70/72 significantly increased from those supplemented with placebo (p <0.0001) and association with levels of Plasma levels of HSP27 (total) and HSP70/72 were increased in women supplemented with DV when compared to women in the placebo group. Based on this finding, verified by the multiplex immunoassay technique, HSP27 (total) levels were found to have large effects (r = 0.63). In addition, HSP70/72 levels were increased in women supplemented with hydroxyvitamin D compared to women in the placebo group, however, in a small effect size, r = 0.32. | — |
Countries
Brazil
Contacts
Public ContactEliana Nahás
Faculdade de Medicina de Botucatu - UNESP
Outcome results
None listed