Effect of Vitamins on Academic Performance of School Children

January 4, 2007 updated by: University of Medicine and Dentistry of New Jersey

Effect of a Randomized Trial of Multivitamin-Mineral Supplementation on Standardized Assessment of Academic Performance in Elementary School Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

SUMMARY OF PROPOSED PROJECT IN LAY TERMS:

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.

Letters will be mailed to parents of all entering third through sixth graders in the Newark School System in August, explaining the study and containing a self-addressed stamped postcard. The postcard will allow parents to express whether or not they wish to be invited to an informational meeting. Location of the meeting will be determined in consultation with the school system. During the meetings, dinner will be served and further information about the study will be disseminated. At the end of the meetings, the informed consent/assent process will be undertaken by the PI and study personnel. Children who are currently taking multivitamins at least five days per week or did not take the Assessment of Skills and Knowledge exam at the completion of the third (3rd) grade will be excluded. Children taking a multivitamin less than five days per week will be eligible if they discontinue its use during the study period. Presentations at the Parent/Teacher Conferences at the beginning of the academic year by Investigators will also be utilized to help answer questions about participation and identify potential volunteers.

Once informed consent and assent have been received, all children will be randomly assigned to receive either 2 tablets of a multivitamin-mineral supplement or 2 tablets of an inactive placebo daily (Monday - Friday when school is in session) in school. The multivitamin-mineral supplement will be analyzed by the United States Pharmacopeial Convention, Inc. (USP) to assure the supplement (1) contains the declared vitamin and mineral ingredients on the product label, (2) contains the amount or strength of ingredients declared on the product label, (3) meets requirements for limits on known contaminants, and (4) otherwise conforms to the USP monograph for the article (Appendix F). Children will receive these tablets in ID numbered envelopes distributed by teachers or study personnel with the morning snacks during the school week for a seven (7) to eight (8) month period in the school year. Pill counts and attendance records will help assess treatment compliance. Participants will receive $10 and free vitamins for one year following the completion of the study.

In order to assess academic performance, information on grade point average, missed days of school and performance on the State of New Jersey's standardized Assessment of Skills and Knowledge (ASK) exam for grades 3, 4, 5 and 6 for each participating child will be obtained from the student record. Demographic information including height, weight, body mass index, age, race and gender will be collected on all children. Height and weight will be measured in the schools by study personnel at the beginning and end of the study period. On a subset of children (n=250, the Block Food Frequency Questionnaire for children will be administered by study personnel at the beginning of the study period to ascertain a record of nutritional intake.

Study Type

Interventional

Enrollment

1600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07018
        • University Of Medicine & Dentistry Of New Jersey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Assessment of Skills and Knowledge Exam

Secondary Outcome Measures

Outcome Measure
Absenteeism
Gradepoint average
Incidents of misbehavior

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Medicine and Dentistry of New Jersey

Collaborators

Rutgers University

Investigators

  • Principal Investigator: Adam ' Perlman, MD, MPH, University Of Medicine & Dentistry Of New Jersey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Study Completion

November 1, 2005

Study Registration Dates

First Submitted

January 3, 2007

First Submitted That Met QC Criteria

January 4, 2007

First Posted (Estimate)

January 5, 2007

Study Record Updates

Last Update Posted (Estimate)

January 5, 2007

Last Update Submitted That Met QC Criteria

January 4, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-681

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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