Effect of Maternal Supplementation with Vitamin A, offered at different intervals, on vitamin A concentrations in breast milk and on the nutritional status of the mother and baby

Impact of Maternal Supplementation with Double Megadose of Vitamin A administered at different intervals on the composition of the mother's milk and nutritional status of the mother-child binomial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-5xgjwm

Enrollment

Unknown

Registered

2019-07-02

Start date

2011-07-01

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

Vitamin A deficiency.

Interventions

Experimental group 1: 30 women will receive orally a megadose of retinyl palmitate (200,000 IU) in the immediate postpartum. Experimental group 2:30 women will orally receive a megadose of retinyl pal

Dietary supplement

G07.203.300.456

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 40 years. Low obstetric risk

Exclusion criteria

Exclusion criteria: Diabetes. Hypertension. Neoplasms. Diseases of the gastrointestinal tract. Liver diseases. Cardiovascular diseases. Infectious diseases. Mental disorder. Preterm birth, Twin pregnancy. Congenital malformations. Cerebral palsy. Supplementation with vitamin A during gestation

Design outcomes

Primary

Measure	Time frame
To evaluate the increase in the concentration of retinol in breast milk, verified by the high performance liquid chromatography method, based on a variation of at least 0.3 micromol / L (80% power and 95% confidence) between the four groups at the end of the follow-up.;There was a change in the concentration of retinol in breast milk using the high-performance liquid chromatography method, based on the finding that the maximum increase among treatment groups was 0.16 micromol / L at the end of follow-up	—

Measure

Time frame

To evaluate the increase in the concentration of retinol in breast milk, verified by the high performance liquid chromatography method, based on a variation of at least 0.3 micromol / L (80% power and 95% confidence) between the four groups at the end of the follow-up.;There was a change in the concentration of retinol in breast milk using the high-performance liquid chromatography method, based on the finding that the maximum increase among treatment groups was 0.16 micromol / L at the end of follow-up

—

Secondary

Measure	Time frame
To evaluate the biochemical (serum) nutritional status of maternal vitamin A at the beginning of the study, using the high-performance liquid chromatography method, based on the fact that serum retinol levels below 0.7 micromol / L maternal vitamin A.;At the beginning of the study, using the high-performance liquid chromatography method, it was found that, when the nutritional state of vitamin A was evaluated from the general retinol mean in the population, it was adequate (1.24 micromol / L). Vitamin A deficiency was observed in 21.5% of the women, since they had retinol concentrations lower than 0.7 micromol / L in the serum.;To assess the biochemical nutritional status (umbilical cord serum) of the baby's vitamin A at the start of the study using the high-performance liquid chromatography method, based on the fact that serum retinol levels below 0.7 micromol / L have configured status mismatch.;At the beginning of the study, using the high-performance liquid chromatography method, it was found that when the nutritional state of vitamin A was evaluated from the general retinol mean in the infant population, it was adequate (0.77 micromol / L). The low vitamin A status was found in 41.5% of the babies, since they had retinol concentrations below 0.7 micromol / L in the umbilical cord serum.	—

Measure

Time frame

To evaluate the biochemical (serum) nutritional status of maternal vitamin A at the beginning of the study, using the high-performance liquid chromatography method, based on the fact that serum retinol levels below 0.7 micromol / L maternal vitamin A.;At the beginning of the study, using the high-performance liquid chromatography method, it was found that, when the nutritional state of vitamin A was evaluated from the general retinol mean in the population, it was adequate (1.24 micromol / L). Vitamin A deficiency was observed in 21.5% of the women, since they had retinol concentrations lower than 0.7 micromol / L in the serum.;To assess the biochemical nutritional status (umbilical cord serum) of the baby's vitamin A at the start of the study using the high-performance liquid chromatography method, based on the fact that serum retinol levels below 0.7 micromol / L have configured status mismatch.;At the beginning of the study, using the high-performance liquid chromatography method, it was found that when the nutritional state of vitamin A was evaluated from the general retinol mean in the infant population, it was adequate (0.77 micromol / L). The low vitamin A status was found in 41.5% of the babies, since they had retinol concentrations below 0.7 micromol / L in the umbilical cord serum.

—

Countries

Brazil

Contacts

Public ContactDanielle Bezerra

Universidade Federal do Rio Grande do Norte

dani_querubim@yahoo.com.br+55-084 3291-2411

Outcome results

None listed

Source: REBEC (via WHO ICTRP)