Effect of maternal vitamin A supplementation on vitamins A and E in breast milk.

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-4v7j2d
• Date of registration: 18/05/2015
• Prospective Registration: No
• Primary sponsor: Universidade Federal do Rio Grande do Norte (Centro Cordenador)
• Public title: Effect of maternal vitamin A supplementation on vitamins A and E in breast milk.
• Scientific title: Assessment of maternal vitamin A supplementation on the retinol levels and alpha-tocopherol in human milk.
• Date of first enrolment: 01/12/2013
• Recruitment status: Recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-4v7j2d
• Study type: Intervention
• Study design: Prevention trial, randomized, controlled, parallel, open, with three arms.
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Roberto Dimenstein
• Affiliation: Universidade Federal do Rio Grande do Norte

• Name: Evellyn Câmara Grilo
• Affiliation: Universidade Federal do Rio Grande do Norte

Key inclusion & exclusion criteria

Inclusion criteria: Healthy volunteers; term delivery; conception without defect; aged 18-45 years; without a history of miscarriage; without the use of vitamin supplements during pregnancy containing vitamin A or E.
Exclusion criteria: Premature birth; diagnosis of gastrointestinal, infectious, liver, heart, syphilis, HIV positive or neoplasms; conceptus multiple; with use of vitamin supplements during pregnancy containing vitamin A or E.

Age minimum: 18Y
Age maximum: 45Y
Gender: F

Health Condition(s) or Problem(s) studied

E56.0

Vitamin E deficiency or vitamin A in the mother and newborn, maternal supplementation.

Intervention(s)

Group 1 (control): 22 women with births at term, untreated, will not receive vitamin A supplementation after delivery, samples will be collected in 3 different days, distributed as follows: first collection in the first 24 hours after delivery, the second sample will be taken 24 hours after the first and third 30 days after birth. The first day will be collected blood and breast milk, on the other days only breast milk. All samples will be collected in the morning and being the mother fasting.
Group 2 (with treatment): 22 women with births at term, they will receive vitamin A supplementation orally in a single dose by a capsule of 200,000 IU of vitamin A (provided by the Ministry of Health) after delivery, samples will be collected in 3 different days, distributed as follows: first collection in the first 24 hours after birth, the second collection will be performed 24 hours after the first and the third 30 days after delivery. The first day will be collected blood and breast milk, on the other days only breast milk. All samples will be collected in the morning and being the mother fasting.
Group 3 (with treatment): 22 women with births at term, they will receive vitamin A supplementation orally in a single dose of 200,000 IU of vitamin A (in liquid form) after delivery, samples will be collected in 3 different days, being distributed as follows: first collection in the first 24 hours after birth, the second collection will be performed 24 hours after the first and the third 30 days after delivery. The first day will be collected blood and breast milk, on the other days only breast milk. All samples will be collected in the morning and being the mother fasting.

Dietary supplement

J02.500.456

Primary Outcome(s)

Increase in retinol concentration and reduction of alpha-tocopherol concentration in breast milk in 30 days, after supplementation, verified by the Student t test from the variation of finding these vitamin concentrations in colostrum and mature milk.

Secondary Outcome(s)

Increasing concentrations of retinol and a reduction of alpha-tocopherol concentration in colostrum milk within 24 hours after supplementation verified by the Student t test variation from finding these vitamin concentrations in colostrum milk, before and after supplementation.

Source(s) of Monetary Support

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Secondary Sponsor(s)

Universidade Federal do Rio Grande do Norte (Centro Cordenador)