Impact of Maternal Supplementation With Dual Megadose of Vitamin A

• Sponsor: Instituto Materno Infantil Prof. Fernando Figueira (Other)
• Overall Status: Completed
• CT.gov ID: NCT00742937
• Collaborator: (none)
• Enrollment: 239
• Location: 1
• Arms: 2
• Duration (Months): 17.1
• Patients Per Site Per Month: 14

Study Details

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
• 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: Jul 1, 2007
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Dec 1, 2008

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 [six months]

Secondary Outcome Measures

1. Morbidity and growth of the child. [six months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Pregnant low-risk obstetric

Exclusion Criteria:

• Premature birth

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Materno Infantil Prof. Fernando Figueira	Recife	Pernambuco	Brazil

Sponsors and Collaborators

• Instituto Materno Infantil Prof. Fernando Figueira

Investigators

• Principal Investigator: Ilma Kruze, PhD,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00742937
• Other Study ID Numbers: IMIPVITA-001
• First Posted: Aug 28, 2008
• Last Update Posted: Jul 29, 2009
• Last Verified: Jul 1, 2009

• Keywords provided by , ,: Hypovitaminosis A
• Additional relevant MeSH terms: Night Blindness; Avitaminosis; Vitamin A Deficiency; Vitamin A

Study Results

No Results Posted as of Jul 29, 2009