NCT00742937

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 26, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

July 29, 2009

Status Verified

July 1, 2009

Enrollment Period

1.1 years

First QC Date

August 26, 2008

Last Update Submit

July 28, 2009

Conditions

HypovitaminosisVitamin A Deficiency

Keywords

Hypovitaminosis A

Outcome Measures

Primary Outcomes (1)

  • Seric retinol

    six months

Secondary Outcomes (1)

  • Morbidity and growth of the child.

    six months

Study Arms (2)

A

PLACEBO COMPARATOR

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

B

EXPERIMENTAL

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

Interventions

vitamin ADIETARY_SUPPLEMENT

second capsule 200,000 UI of retinol palmitate (vitamin A)plus vitamin E, eight days after delivery.

B
PlaceboDIETARY_SUPPLEMENT

second capsule with vitamin E, eight days after delivery.

A

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant low-risk obstetric

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Materno Infantil Prof. Fernando Figueira

Recife, Pernambuco, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 26725194DERIVED

  • 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.

    PMID: 24455219DERIVED

  • 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.

    PMID: 22412025DERIVED

MeSH Terms

Conditions

AvitaminosisVitamin A Deficiency

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

Deficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

RetinoidsCarotenoidsPolyenesAlkenesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicTerpenesDiterpenesPigments, BiologicalBiological Factors

Study Officials

  • Ilma Kruze, PhD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 26, 2008

First Posted

August 28, 2008

Study Start

July 1, 2007

Primary Completion

August 1, 2008

Study Completion

December 1, 2008

Last Updated

July 29, 2009

Record last verified: 2009-07

Locations

BR(1)