Impact of Maternal Supplementation With Dual Megadose of Vitamin A - Full Text View

Sponsored by:	Instituto Materno Infantil Prof. Fernando Figueira
Information provided by:	Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:	NCT00742937

Purpose

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
Hypovitaminosis Vitamin A Deficiency	Dietary Supplement: vitamin A Dietary Supplement: Placebo	Phase II Phase III

MedlinePlus related topics: Dietary Supplements

Drug Information available for: Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Vitamin A Retinol

U.S. FDA Resources

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

Further study details as provided by Instituto Materno Infantil Prof. Fernando Figueira:

Primary Outcome Measures:

Seric retinol [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Morbidity and growth of the child. [ Time Frame: six months ] [ Designated as safety issue: No ]

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
A: Placebo Comparator	Dietary Supplement: Placebo second capsule with vitamin E, eight days after delivery.
B: Experimental	Dietary Supplement: vitamin A second capsule 200,000 UI of retinol palmitate (vitamin A)plus vitamin E, eight days after delivery.

Detailed Description:

The effect will be assessed by the milk and blood.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Pregnant low-risk obstetric

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742937

Locations

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

Sponsors and Collaborators

Instituto Materno Infantil Prof. Fernando Figueira

Investigators

Principal Investigator:

Ilma Kruze, PhD

Unaffiliated

More Information

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

Keywords provided by Instituto Materno Infantil Prof. Fernando Figueira:

Hypovitaminosis A

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Anticarcinogenic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Growth Substances

Vitamins
Physiological Effects of Drugs
Micronutrients
Protective Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009