Plain English Summary
Background and study aims
Nutritional deficiencies have occurred in military units throughout history, significantly compromising the health of Service Members (SMs) and the operational effectiveness of military units. For example, scurvy disabled many sailors in the British Royal Navy and during the United States (US) Civil War, a lack of appreciation that vitamin A deficiency resulted in night blindness caused many physicians to ascribe this medical condition to malingering. With improved understanding of the links between nutrition and diseases these and other nutrition-related maladies have been largely ameliorated. Nonetheless, nutritional status remains an important issue for military populations. Deficiencies in critical minerals, vitamins, and other nutritional constituents have been reported among US SMs and these have been shown to affect SM health and performance. For example, iron is a critical micronutrient that is incorporated into proteins and enzymes and is important for physical, cognitive, and immune functioning. In longitudinal studies, markers of iron status were found to decline during deployment among Special Operations Soldiers, as well as during military training among male and female soldiers and this was associated with a decline in aerobic performance. The prevalence of iron deficiency and iron deficiency anemia was documented to be as high as 33% and 21%, respectively, among female personnel during Army Basic Training and in Advanced Individual Training. Another example is vitamin D which is essential for maintaining bone health. Vitamin D sufficiency, measured with 25-hydroxyvitamin D (25(OH)D), was found to decline during Basic Combat Training (BCT) among women. It is well established that stress fracture rates in BCT are higher among women compared to men, and lower levels of 25(OH)D have been associated with increased risk of stress fractures in a number of military investigations. This study will examine clinically-diagnosed vitamin and mineral deficiencies in the entire US military population. The specific aims are to: describe the overall incidence of clinically-diagnosed vitamin and mineral deficiencies in all military services, describe temporal trends in clinically-diagnosed nutritional deficiencies in all military services, and examine associations between the incidence of nutritional deficiencies and demographic characteristics that include sex, age, race and military service.
Who can participate?
All active-duty US military service members (Army, Navy, Air Force, Marines) serving in the inclusive years 1997-2015
What does the study involve?
Compilation and examination of clinically-diagnosed vitamin and mineral deficiencies obtained from the Defense Medical Epidemiology Database (DMED). Vitamin and mineral deficiencies will be identified from specific International Classification of Diseases, Ninth Revision (ICD-9) codes.
What are the possible benefits and risks of participating?
This is an examination of existing de-identified medical data. Thus, the study poses no physical risks to the participants. Benefits include identification of the incidence and longitudinal trends in vitamin and mineral deficiencies. Subpopulations (by sex, age, race and military service) that might be at higher risk will also be identified for each vitamin and mineral deficiency.
Where is the study run from?
The US Army Research Institute of Environmental Medicine (USA)
When is the study starting and how long is it expected to run for?
February 2019 to June 2020
Who is funding the study?
The US Army Research Institute of Environmental Medicine (USA)
Who is the main contact?
Dr Joseph Knapik
joseph.j.knapik.ctr@mail.mil
Trial website
Contact information
Type
Scientific
Primary contact
Dr Joseph Knapik
ORCID ID
http://orcid.org/0000-0002-1568-1860
Contact details
10 General Greene Ave
Natick
01760
United States of America
+1 (0)4437523350
joseph.j.knapik.ctr@mail.mil
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Clinically-diagnosed vitamin and mineral deficiencies in the entire population of the United States military, 1997-2015
Acronym
Study hypothesis
Hypothesis 1: The incidence of nutritional deficiencies in SMs will increase during the period examined.
Hypothesis 2: The incidence of nutritional deficiencies in SMs will differ by the demographic characteristics of the military population (e.g., sex, age, race, and military service).
Ethics approval
The Office of Research Quality and Compliance at the US Army Research Institute of Environmental Medicine (USARIEM) judged that since this study involved a publicly available database and had no personal identifiers the study did not constitute human subjects research and was exempt.
United States Army Research Institute of Environmental Medicine (USARIEM) Office of Research Quality and Compliance (10 General Greene Ave, Natick MA 01760; Tel +1 (0)508 233 5319; Email: usarmy.natick.medcom-usariem.list.usariem-rqc@mail.mil)
Study design
Retrospective cohort study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Other
Trial type
Other
Patient information sheet
Condition
Clinically-diagnosed vitamin and mineral deficiencies
Intervention
Data will be extracted from a pre-existing database, the Defense Medical Epidemiological Database (DMED) to obtain information on the incidence of vitamin and mineral deficiencies, examine associations with demographic factors (age, sex, race, military service), and examine trends over time. The DMED does not contain any personal identifiers. Standard statistical measures will be employed to analyze the data (descriptive statistics, chi-square, linear regression).
Intervention type
Other
Phase
Drug names
Primary outcome measure
Vitamin and mineral deficiencies and disorders extracted from the Defense Medical Epidemiology Database for the years 1997 to 2015
Secondary outcome measures
There are no secondary outcome measures
Overall trial start date
01/02/2019
Overall trial end date
13/06/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All active-duty US military service members in the US Army, Navy, Air Force and Marines serving between 1997 and 2015
Participant type
Other
Age group
Adult
Gender
Both
Target number of participants
All active duty US military service members in the US Army, Navy, Air Force and Marines serving between 1997 and 2015. The military population varied between 1,302,810 and 1,425,823 in the years 1997 to 2015. The average+_standard deviation for the period was 1,382,266+_30,987.
Total final enrolment
1382266
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
04/04/2019
Recruitment end date
30/08/2019
Locations
Countries of recruitment
United States of America
Trial participating centre
US Army Research Institute of Environmental Medicine
10 General Greene Ave
Natick, MA
01760
United States of America
Sponsor information
Organisation
US Army Research Institute of Environmental Medicine
Sponsor details
10 General Greene Ave
Natick
01760
United States of America
+1 (0)4437523350
joseph.j.knapik.ctr@mail.mil
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
U.S. Army Research Institute of Environmental Medicine
Alternative name(s)
United States Army Research Institute of Environmental Medicine, US Army Research Institute of Environmental Medicine, USARIEM
Funding Body Type
government organisation
Funding Body Subtype
Research institutes and centers
Location
United States of America
Results and Publications
Publication and dissemination plan
Results will be published in peer-reviewed journals and presented at scientific meetings.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Joseph Knapik (joseph.j.knapik.ctr@mail.mil).
Type of data:
1. Number of cases for specific ICD-9 codes indicative of clinically diagnosed vitamin and mineral deficiencies and disorders.
2. Population data for each year of the survey.
When data will become available and for how long:
Data should be available by 18/12/2019 for a two year period.
Access criteria data will be shared including with whom, for what types of analyses, and by what mechanism: Data will be shared with any clinical medical care provider or researcher on reasonable request with justification. Each request will be judged individually. Data sharing must be approved by the US Army Research Institute of Environmental Medicine Commander or higher military authority. Data will be sent by postal mail.
Was consent from participants was obtained:
Consent was not obtained because the study was judged by an IRB to be non-human and exempt. This is because data was de-identified and in a publically accessible database.
Data anonymisation:
Data is de-identified.
Ethical or legal restrictions, any other comments.
Any publication, presentation, or any form of publicly available access must be approved by the US Army Research Institute of Environmental Medicine Commander or higher military authority.
Intention to publish date
18/12/2019
Participant level data
Available on request
Basic results (scientific)
Publication list