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NCT01106183 Clinical Trial

Efficacy of Transfer Factor to Prevent Upper Respiratory Tract Infections in Healthy Adults

Upper Respiratory Tract Infections Due to Influenza or Rhinovirus Clinical Trial

Official title:
A Double Blind Study on the Efficacy of a Colostrum and Egg Yolk Supplement vs. Placebo to Reduce Frequency and Duration of Upper Respiratory Tract Infections in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01106183
Other study ID # 38766 4Life-Transfer Factor
Secondary ID
Status Completed
Phase N/A
First received April 15, 2010
Last updated November 14, 2011
Start date January 2010

Study information
Verified date November 2011
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: University of Utah Institutional Review Board
Study type Interventional

Clinical Trial Summary

The goals of our study are to critically evaluate if a healthy population supplemented with Transfer factor experiences fewer incidences of colds and flu, or experience shorter duration of illness compared to an identical population taking placebo. In this study we will give either Transfer factor or a placebo to two groups of healthy adult men and women for a period of 7 weeks in a double-blind experimental design. The frequency and duration of colds and flu-like symptoms will be recorded during the course of the study. Saliva samples will be collected weekly and assessed for salivary IgA secretion rate. Data from this study will establish the efficacy of Transfer Factor to support a healthy immune system.

Recruitment information / eligibility
Status Completed
Enrollment 49
Est. completion date
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Males and females (18 - 40) who are in good health

Exclusion Criteria:

- Subjects who are allergic to eggs (on which the supplement is based). If a volunteer is not sure if they are allergic to eggs or milk. Those who are currently smoking, have cardiovascular disease, cancer, diabetes, liver disease, renal insufficiency, any chronic disease that might interfere with study participation, BMI above 40 kg/m2, consumption of >12 alcoholic drinks weekly, or unwillingness to stop current supplement intake. Women who are pregnant or lactating will also be excluded from the study.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• transfer factor
capsules, 2 per day by mouth for 7 weeks.
• Placebo
cornstarch, 2 capsules per day by mouth.

Locations
Country Name City State
United States University of Utah Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States,