Impact of Maternal Supplementation With Dual Megadose of Vitamin A

This study has been completed.
Sponsor:
Information provided by:
Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov Identifier:
NCT00742937
First received: August 26, 2008
Last updated: July 28, 2009
Last verified: July 2009
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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 ]

Enrollment: 239
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: placebo
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.
Other Name: Vitamin A

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Instituto Materno Infantil Prof. Fernando Figueira

Additional 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
Study First Received: August 26, 2008
Last Updated: July 28, 2009
Health Authority: Brazil: Ethics Committee

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

Additional relevant MeSH terms:
Avitaminosis
Night Blindness
Vitamin A Deficiency
Deficiency Diseases
Eye Diseases
Malnutrition
Nutrition Disorders
Vision Disorders
Retinol palmitate
Vitamin A
Vitamins
Anticarcinogenic Agents
Antineoplastic Agents
Antioxidants
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014