FLUVIT: A Double-Blind Randomized, Placebo Controlled Study of Antibody Induction By Vitamin Supplementation At The Time Of Influenza Virus Vaccination In Children

Categories:

Infectious Diseases

Vaccines

Eligibility Overview:

  • Participant is age two (2) to eight (8) years inclusive at the time of enrollment.
  • Participant is not currently using investigational or immunosuppressive drugs (e.g. steroids) at the time of enrollment.
  • Participant is not currently taking a daily (routine) Vitamin A, D or multi-vitamin. Note: Participant who report occasional or sporadic vitamin use will be allowed to enroll.

Description

This study is enrolling participants who are healthy, eligible, and who volunteer to be in this study.  Children are particularly at risk for getting respiratory virus infections and vaccination is the single best way to prevent infectious diseases. Children with vitamin A and D deficiencies are vulnerable to respiratory tract diseases as well. This study will seek to determine if children that take vitamins with their flu vaccine have a better immune response than those that do not. Those who are eligible will be in this study about sixty-six (66) days.

Primary Objectives

  • To estimate the IgA (Antibody) response (in the respiratory system and blood) of participants to influenza vaccine.

Exploratory Objectives:

  • To describe the socio-demographic characteristics, and diet among children participating in the trial.
  • To assess the feasibility of the food diary among healthy volunteers as measured by completion of the diary.
  •  To monitor serum Vitamin A and D levels in participants at various time points

Eligibility (among others)

  • Participant is age two (2) to eight (8) years inclusive at the time of enrollment.
  • Participant is not currently using investigational or immunosuppressive drugs (e.g. steroids) at the time of enrollment.
  • Participant is not currently taking a daily (routine) Vitamin A, D or multi-vitamin. Note: Participant who report occasional or sporadic vitamin use will be allowed to enroll.
  • Participant has no history of lung disease, asthma, hospitalization for respiratory illness, immunodeficiency, sickle cell disease, or any other serious underlying condition or disease in the opinion of the principal investigator. 
  • Participant has no history of life-threatening reaction to influenza vaccinations.
  • Participant has not used an anti-influenza medication (including amantadine, rimantadine, oseltamavir, and zanamivir) within fourteen (14) days prior to enrollment.
  • Participant has not received current seasonal influenza vaccine.
FLUVIT Quick View
Sponsor St. Jude Children’s Research Hospital 
Clinicaltrials.gov identifier NCT02649192
Trial start date January 2016
Estimated enrollment 80
Study type Interventional/Therapeutic
Study Phase

Phase II

Conditions Healthy Participants
Ages 2 to 8 years
Principal investigator Nehali Patel, MD
Study site St. Jude Children’s Research Hospital
For a consultation or to discuss FLUVIT St. Jude Healthy Volunteers
901-264-3969
volunteer.studies@stjude.org

Principal Investigator

Nehali Patel, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 901-264-3969
Email: volunteer.studies@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.