NCT00418990

Brief Summary

The purpose of this clinical trial is to determine if administration of a daily chewable multivitamin-mineral supplement (Monday - Friday when school is in session) given to children (third through sixth graders) during the academic school year will lead to improved academic performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2003

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2007

Completed
Last Updated

January 5, 2007

Status Verified

January 1, 2007

First QC Date

January 3, 2007

Last Update Submit

January 4, 2007

Conditions

Malnutrition

Keywords

MultivitaminAcademic performance

Outcome Measures

Primary Outcomes (1)

  • Assessment of Skills and Knowledge Exam

Secondary Outcomes (3)

  • Gradepoint average

  • Absenteeism

  • Incidents of misbehavior

Interventions

Multivitamin/Mineral supplementsDRUG

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Enrollment in third through sixth grades in the Archdiocese of Newark School System during 2004-2005 academic year.
  • Completion of the Assessment of Skills and Knowledge Exam in 2003

You may not qualify if:

  • Known allergy to any ingredients of the multivitamin.
  • Currently taking a multivitamin on a regular basis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Medicine & Dentistry of New Jersey

Newark, New Jersey, 07018, United States

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Geritol

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Adam ' Perlman, MD, MPH

    University of Medicine & Dentistry of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 3, 2007

First Posted

January 5, 2007

Study Start

August 1, 2003

Study Completion

November 1, 2005

Last Updated

January 5, 2007

Record last verified: 2007-01

Locations

US(1)