Evaluation of maternal supplementation with vitamin E and its influence on breast milk
Not Applicable
- Conditions
- Acquired haemolytic anaemia, Dietary Supplements, nutritional deficiency, Obstetric Labor, PrematureJ02.500.456C18.654.521.500C13.703.420.491
- Registration Number
- RBR-9gycqb
- Lead Sponsor
- niversidade Federal do Rio Grande do Norte
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruitment completed
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Healthy lactating preterm births; single conceptus without malformation; aged 18-40 years; no history of abortion; without the use of vitamin supplements during pregnancy
Exclusion Criteria
Women with term delivery, ie, greater than 37 weeks gestation; that are experiencing conditions such as diseases of the gastrointestinal tract and liver, heart disease, infectious syphilis, HIV positive and neoplasia; multiple conceptus; who used vitamin supplements during pregnancy containing vitamin E.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Expected outcome: Increased alpha-tocopherol concentration in breast milk in the supplemented group, within 30 days. To increase the verified, we will use the high performance liquid chromatography method compared with a standard. For determining the expected outcome, were taken into account the effect size d = 0.3, alpha 0.05, test the power of 0.8 and a 95% confidence interval. Under these parameters, the minimum sample size required was 38 subjects for each group.;Outcome found: Increased alpha-tocopherol concentration in breast milk in the supplemented group, in the period up to 7 days. The method used to quantify the tocopherol was chromatographed high efficiency, based on comparison to a standard alpha-tocopherol. The study included 89 women distributed in the control group (n = 51) and supplemented group (n = 38).
- Secondary Outcome Measures
Name Time Method