Impact of Maternal Supplementation With Dual Megadose of Vitamin A
Primary Purpose
Hypovitaminosis, Vitamin A Deficiency
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
vitamin A
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Hypovitaminosis focused on measuring Hypovitaminosis A
Eligibility Criteria
Inclusion Criteria:
- Pregnant low-risk obstetric
Exclusion Criteria:
- Premature birth
- Newborn babies with birth defects and / or other serious diseases
Sites / Locations
- Instituto Materno Infantil Prof. Fernando Figueira
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
A
B
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Seric retinol
Secondary Outcome Measures
Morbidity and growth of the child.
Full Information
NCT ID
NCT00742937
First Posted
August 26, 2008
Last Updated
July 28, 2009
Sponsor
Instituto Materno Infantil Prof. Fernando Figueira
1. Study Identification
Unique Protocol Identification Number
NCT00742937
Brief Title
Impact of Maternal Supplementation With Dual Megadose of Vitamin A
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 Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Instituto Materno Infantil Prof. Fernando Figueira
4. Oversight
Data Monitoring Committee
Yes
5. 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.
Detailed Description
The effect will be assessed by the milk and blood.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovitaminosis, Vitamin A Deficiency
Keywords
Hypovitaminosis A
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
239 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin A
Intervention Description
second capsule 200,000 UI of retinol palmitate (vitamin A)plus vitamin E, eight days after delivery.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
second capsule with vitamin E, eight days after delivery.
Primary Outcome Measure Information:
Title
Seric retinol
Time Frame
six months
Secondary Outcome Measure Information:
Title
Morbidity and growth of the child.
Time Frame
six months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant low-risk obstetric
Exclusion Criteria:
Premature birth
Newborn babies with birth defects and / or other serious diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilma Kruze, PhD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Materno Infantil Prof. Fernando Figueira
City
Recife
State/Province
Pernambuco
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
26725194
Citation
Tomiya MT, de Arruda IK, da Silva Diniz A, Santana RA, da Silveira KC, Andreto LM. The effect of vitamin A supplementation with 400 000 IU vs 200 000 IU on retinol concentrations in the breast milk: A randomized clinical trial. Clin Nutr. 2017 Feb;36(1):100-106. doi: 10.1016/j.clnu.2015.11.018. Epub 2015 Dec 17.
Results Reference
derived
PubMed Identifier
24455219
Citation
Dos Santos CS, Kruze I, Fernandes T, Andreto LM, Figueiroa JN, Diniz Ada S. The Effect of a Maternal Double Megadose of Vitamin A Supplement on Serum Levels of Retinol in Children Aged under Six Months. J Nutr Metab. 2013;2013:876308. doi: 10.1155/2013/876308. Epub 2013 Dec 24.
Results Reference
derived
PubMed Identifier
22412025
Citation
Fernandes TF, Figueiroa JN, Grande de Arruda IK, Diniz Ada S. Effect on infant illness of maternal supplementation with 400 000 IU vs 200 000 IU of vitamin A. Pediatrics. 2012 Apr;129(4):e960-6. doi: 10.1542/peds.2011-0119. Epub 2012 Mar 12.
Results Reference
derived
Learn more about this trial
Impact of Maternal Supplementation With Dual Megadose of Vitamin A
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