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Impact of Maternal Supplementation With Dual Megadose of Vitamin A

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ClinicalTrials.gov Identifier: NCT00742937
Recruitment Status : Completed
First Posted : August 28, 2008
Last Update Posted : July 29, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Hypovitaminosis Vitamin A Deficiency Dietary Supplement: vitamin A Dietary Supplement: Placebo Phase 2 Phase 3

Detailed Description:
The effect will be assessed by the milk and blood.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 239 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : July 2007
Primary Completion Date : August 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: A
After birth the women will receive one capsule 200,000 UI of retinol palmitate (vitamin A)plus vitamin E and eight days after delivery the second capsule of vitamin E will be administer.
Dietary Supplement: Placebo
second capsule with vitamin E, eight days after delivery.
Experimental: B
After birth the women will receive one capsule 200,000 UI of retinol palmitate (vitamin A)plus vitamin E and eight days after delivery the second capsule of 200,000 UI of retinol palmitate (vitamin A)plus vitamin E will be administer.
Dietary Supplement: vitamin A
second capsule 200,000 UI of retinol palmitate (vitamin A)plus vitamin E, eight days after delivery.


Outcome Measures

Primary Outcome Measures :
  1. Seric retinol [ Time Frame: six months ]

Secondary Outcome Measures :
  1. Morbidity and growth of the child. [ Time Frame: six months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00742937


Locations
Brazil
Instituto Materno Infantil Prof. Fernando Figueira
Recife, Pernambuco, Brazil
Sponsors and Collaborators
Instituto Materno Infantil Prof. Fernando Figueira
Investigators
Principal Investigator: Ilma Kruze, PhD
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ilma Kruse Grande de Arruda, Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier: NCT00742937     History of Changes
Other Study ID Numbers: IMIPVITA-001
First Posted: August 28, 2008    Key Record Dates
Last Update Posted: July 29, 2009
Last Verified: July 2009

Keywords provided by Instituto Materno Infantil Prof. Fernando Figueira:
Hypovitaminosis A

Additional relevant MeSH terms:
Avitaminosis
Vitamin A Deficiency
Night Blindness
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Eye Diseases
Vitamins
Vitamin E
Tocopherols
Tocotrienols
alpha-Tocopherol
Vitamin A
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents