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Evaluation of maternal supplementation with vitamin E and its influence on breast milk

Evaluation of maternal supplementation with vitamin E in its natural form (ethyl RRR-alpha-tocopherol) or synthetic (ethyl all-rac-alpha-tocopherol) on the levels of alpha-tocopherol in different stages of breast milk

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9gycqb
Enrollment
Unknown
Registered
2015-04-25
Start date
2013-11-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired haemolytic anaemia, Dietary Supplements, nutritional deficiency, Obstetric Labor, Premature

Interventions

Group 1 (control ) : 30 women with premature delivery ( < 37 weeks gestation) , without treatment , will not receive vitamin E supplementation after delivery , samples will be collected for 4 days, di
Dietary supplement

Sponsors

Universidade Federal do Rio Grande do Norte
Lead Sponsor
Universidade Federal do Rio Grande do Norte (Centro Cordenador)
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Expected outcome: To evaluate the concentration of alpha-tocopherol colostrum milk, transitional and mature in both groups meets the dietary needs of the newborn. To assess whether the daily intakes for children 0-6 months of 4 mg / day was treated at different times of lactation was adopted that premature child ingests 254 ± 125 mL / day of milk in the first week of life and 552 mL / day of mature milk, with a month of life. For finding the expected outcomes will be considered the difference between the value established as normal and the value found in each group evaluated before and after supplementation.;Outcome Found: Only colostrum milk in the group supplemented reach the nutritional recommendations by AI 4 mg / day of vitamin E for babies 0-6 months. For assessment of the criteria was adopted that premature child ingests 254 ± 125 mL / day of milk in the first week of life and 552 mL / day of mature milk, with a month of life. Was found in colostrum milk 0h Control Group 3.8 mg / day of alpha-tocopherol and Group Supplemented 3.4 mg / day. In milk 24h in the control group 3.4 mg / day of alpha-tocopherol while in the group supplemented 5.8 mg / day. In the transitional milk the concentration of alpha-tocopherol / day was 2.2 mg / day and 3.4 mg / day for the supplemented group and control group, respectively. In mature milk 2.4 mg / day for the control group and 2.3 mg / day for Supplemented Group.

Countries

Brazil

Contacts

Public ContactJeane;Jeane Medeiros;Medeiros

Universidade Federal do Rio Grande do Norte (Centro Cordenador);Universidade Federal do Rio Grande do Norte (Centro Cordenador)

jeanefpires@hotmail.com;jeanefpires@hotmail.com+55 (84) 99787518;+558499787518

Outcome results

None listed

Source: REBEC (via WHO ICTRP)