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Sponsored by: |
Instituto Materno Infantil Prof. Fernando Figueira |
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Information provided by: | Instituto Materno Infantil Prof. Fernando Figueira |
ClinicalTrials.gov Identifier: | NCT00742937 |
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.
Condition | Intervention | Phase |
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Hypovitaminosis Vitamin A Deficiency |
Dietary Supplement: vitamin A Dietary Supplement: Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official 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 |
Estimated Enrollment: | 239 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | December 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Placebo Comparator |
Dietary Supplement: Placebo
second capsule with vitamin E, eight days after delivery.
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B: Experimental |
Dietary Supplement: vitamin A
second capsule 200,000 UI of retinol palmitate (vitamin A)plus vitamin E, eight days after delivery.
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The effect will be assessed by the milk and blood.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Brazil, Pernambuco | |
Instituto Materno Infantil Prof. Fernando Figueira | Recruiting |
Recife, Pernambuco, Brazil | |
Contact: Ilma Kruze, Ph.D 55 81 99736122 ilmakruze@hotmail.com | |
Principal Investigator: Ilma Kruze, Ph.D |
Principal Investigator: | Ilma Kruze, PhD | Unaffiliated |
Responsible Party: | Instituto Materno Infantil Prof. Fernando Figueira ( Ilma Kruse Grande de Arruda ) |
Study ID Numbers: | IMIPVITA-001 |
Study First Received: | August 26, 2008 |
Last Updated: | December 10, 2008 |
ClinicalTrials.gov Identifier: | NCT00742937 |
Health Authority: | Brazil: Ethics Committee |
Hypovitaminosis A |
Vitamin A Deficiency Night Blindness Tocopherol acetate Vision Disorders Keratomalacia Avitaminosis Eye Diseases Blindness Alpha-Tocopherol |
Tocopherols Vitamin E Malnutrition Retinol palmitate Vitamin A Nutrition Disorders Iron Deficiency Diseases |
Anticarcinogenic Agents Antioxidants Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Growth Substances |
Vitamins Physiological Effects of Drugs Micronutrients Protective Agents Pharmacologic Actions |