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Completed

NCT Number: NCT00742937

Impact of Maternal Supplementation With Dual Megadose of Vitamin A

The purpose of this study is to evaluate the effect of maternal supplementation with 400,000 IU of oral retinol palmitate in the post-partum, the nutritional situation of the binomial mother-child, on growth and morbidity of children in breastfeeding in the first six months of life.

Completed

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Key information

Conditions

Hypovitaminosis Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Vitamin A Deficiency

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Instituto Materno Infantil Prof. Fernando Figueira

Recife, Pernambuco, Brazil

About this study

The effect will be assessed by the milk and blood.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnant low-risk obstetric

Exclusion criteria

  • Premature birth
  • Newborn babies with birth defects and / or other serious diseases

Treatment and study plan

Vitamin A

Dietary Supplement

second capsule 200,000 UI of retinol palmitate (vitamin A)plus vitamin E, eight days after delivery.

Placebo

Dietary Supplement

second capsule with vitamin E, eight days after delivery.

Primary outcomes

  1. Seric retinol

    Time frame: six months

Secondary outcomes

  1. Morbidity and growth of the child.

    Time frame: six months

Sponsors and collaborators

Lead sponsor

Instituto Materno Infantil Prof. Fernando Figueira

Other

Registry information

Official study title

Impact of Supplementation With Dual Megadose of Vitamin A in the Post-partum About Vitamin A Levels in Breast Milk, Serum Levels of Vitamin A and Iron in the Binomial Mother-son and Growth and Morbidity of Children Under 6 Months

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 28, 2008
Registry last updated
Jul 29, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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