Impact of Maternal Supplementation With Dual Megadose of Vitamin A

Vitamin A Deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742937
• Other study ID #: IMIPVITA-001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 26, 2008
• Last updated: July 28, 2009
• Start date: July 2007
• Est. completion date: December 2008

Study information

• Verified date: July 2009
• Source: Instituto Materno Infantil Prof. Fernando Figueira
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

The effect will be assessed by the milk and blood.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 239
• Est. completion date: December 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant low-risk obstetric

Exclusion Criteria:

• Premature birth

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Avitaminosis
• Hypovitaminosis
• Night Blindness
• Vitamin A Deficiency

Intervention

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

Locations

Country	Name	City	State
Brazil	Instituto Materno Infantil Prof. Fernando Figueira	Recife	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Materno Infantil Prof. Fernando Figueira

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seric retinol		six months	No
Secondary	Morbidity and growth of the child.		six months	No