Effect of Vitamins on Academic Performance of School Children
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

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.
    

Intervention name(s): Multivitamin/Mineral supplements
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Multivitamin; Academic performance