Clinical trial NCT00418990: Effect of Vitamins on Academic Performance of School Children
Official title: Effect of a Randomized Trial of Multivitamin-Mineral Supplementation on Standardized Assessment of Academic Performance in Elementary School Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Keywords: Multivitamin
Academic performance
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Rutgers University
First posted: 2007-01-05
Enrollment: 1600
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of Skills and Knowledge Exam
Secondary outcomes:
measure: Gradepoint average
measure: Absenteeism
measure: Incidents of misbehavior
Other outcomes:
Locations:
city: Newark
country: United States
facility: University of Medicine & Dentistry of New Jersey
state: New Jersey
Study officials:
affiliation: University of Medicine & Dentistry of New Jersey
name: Adam ' Perlman, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: