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Different Doses of Vitamin A Supplementation and Male and Female Morbidity and Mortality

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00168636
First Posted: September 15, 2005
Last Update Posted: November 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bandim Health Project
  Purpose
We previously compared the effect on mortality of the half dose and the full dose currently recommended by WHO. Unexpectedly, the low dose was clearly better for girls, but not for boys. The girls' response might have depended on the last vaccine received before the OPV and VAS campaign. We believe that these findings call for confirmation. In connection with a new campaign, we will examine whether half the dose or the full dose has a more beneficial effect on mortality and morbidity in girls, and furthermore address the potential effect modification by the last vaccine received before the supplementation.

Condition Intervention Phase
Mortality Morbidity Drug: Vitamin A Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Impact of Different Doses of Vitamin A Supplementation on Male and Female Childhood Morbidity and Mortality

Resource links provided by NLM:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • Mortality
  • Morbidity
  • All outcomes are investigated for interactions between vitamin A, sex, and last vaccine received

Secondary Outcome Measures:
  • Rota infection
  • Measles infection
  • Growth

Estimated Enrollment: 11000
Study Start Date: November 2004
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Detailed Description:

In Guinea-Bissau, a combined OPV and VAS campaign took place in November 2002. Given the uncertainty about the best dose of VAS, we examined whether the half dose compared with the full dose currently recommended by WHO gave an equally good protection against childhood morbidity and mortality. Mortality after supplementation was lower, though not significantly so, for children who had received the half dose. However, there was a highly significant inversion of the effect for boys and girls; while the low dose was clearly better for girls, the full dose might have been slightly better for boys. The girls' responses to the high versus the low dose of vitamin A might have depended on the last vaccine received before the OPV and VAS campaign.

We believe that these findings call for confirmation. In connection with the OPV and VAS campaign in November 2004 in Guinea-Bissau, we intend to examined whether half the dose of the dose currently recommended by WHO as compared to the full dose has a more beneficial effect on mortality and morbidity in girls, and furthermore address the potential effect modification by the last vaccine received before the supplementation.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:Between 6 mo and 5 years of age and thus eligible for vitamin A and OPV campaign -

Exclusion Criteria:Overt signs of vitamin A deficiency

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00168636


Locations
Guinea-Bissau
Bandim Health Project, Apartado 861
Bissau, Guinea-Bissau
Sponsors and Collaborators
Bandim Health Project
Investigators
Principal Investigator: Peter Aaby, DMSc Bandim Health Project
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00168636     History of Changes
Other Study ID Numbers: 91096-2dos04
91096-04
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: November 15, 2013
Last Verified: November 2013

Keywords provided by Bandim Health Project:
Vitamin A
Mortality
Morbidity
OPV
Sex

Additional relevant MeSH terms:
Vitamins
Vitamin A
Retinol palmitate
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anticarcinogenic Agents
Antineoplastic Agents