Poster Topical Area: Methods and Protocols

Location: Hall D

Poster Board Number: 693

P15-032 - Adverse Event Reporting in Oral Nutritional Supplement Clinical Trials: A Systematic Review

Monday, Jun 11
8:00 AM – 3:00 PM

Objectives: The primary objective of this study was to systematically collect and review the current state of adverse event (AE) reporting during clinical nutrition trials evaluating the efficacy of oral nutritional supplements (ONS) in adult populations in the United States.


Methods: A keyword search was conducted in PubMed, Web of Science, and Scopus databases retrieving n=422 studies. We included randomized, controlled clinical trials assessing healthy adult populations' (i.e., no active disease, infection, or metabolic disorder) response to an ONS (liquids, or powders which provide macro and micronutrients) in the USA. In the screening phase, two independent reviewers assessed all studies using a 7-point exclusion criteria before deliberation and coming to agreement to retrieve a final n=13 studies to be included in the qualitative synthesis. The following data were extracted from each included study: first author, year, journal, ONS type, study design, population type and number, AE reporting method used, AEs collected, physician oversight, and sections in the paper AEs are discussed and in what manner.


Results: Independent reviewers demonstrated moderate agreement (Cohen's Kappa=0.509) in the initial screening phase. The studies varied in their AE collection/reporting methods including no AE collection/reporting (n=7), to various AE collection/reporting methods (n=6; blood chemistries (n=1), self-reporting (n=4), and a combination of survey responses and blood chemistries (n=1)). A total of 1123 adults were included in the clinical trials, and n=317 AEs from 3 of the 13 studies were reported; n=296 AEs due to self-reporting and n=21 due to survey responses. Only 1 of the 6 studies with AE reporting/collecting mentions a physician oversight and 4 of the 6 explicitly list participant safety as reason for collecting AEs. Detailed information was not provided on AE collection/reporting methodology, as such it was impossible to determine the level of health care professional/medical oversight for many of the trials.


Conclusions: Our findings highlight the inconsistency in the methods of AE reporting of nutritional clinical trials and suggest future work be put forth in creating a framework for AE reporting of ONS and other nutritional products




Funding Source: Abbott Nutrition

CoAuthors: Amy Devitt , PhD – Abbott Nutrition

Anna W. Waller

Graduate Student Research Assistant/ Abbott Nutrition Intern
University of Illinois at Champaign-Urbana
Urbana, Illinois