Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/09/2019
Date assigned
13/09/2019
Last edited
13/09/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

https://www.usariem.army.mil/

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

Publication citations

Additional files

Editorial Notes

13/09/2019: Trial's existence confirmed by funder.