Vitamin and mineral deficiencies in the US military

ISRCTN ISRCTN58987177
DOI https://doi.org/10.1186/ISRCTN58987177
Submission date
10/09/2019
Registration date
13/09/2019
Last edited
26/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Joseph Knapik
Scientific

10 General Greene Ave
Natick
01760
United States of America

ORCiD logoORCID ID 0000-0002-1568-1860
Phone +1 (0)4437523350
Email joseph.j.knapik.ctr@mail.mil

Study information

Study designRetrospective cohort study
Primary study designObservational
Secondary study designLongitudinal study
Study setting(s)Other
Study typeOther
Scientific titleClinically-diagnosed vitamin and mineral deficiencies in the entire population of the United States military, 1997-2015
Study objectivesHypothesis 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(s)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)
Health condition(s) or problem(s) studiedClinically-diagnosed vitamin and mineral deficiencies
InterventionData 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 typeOther
Primary outcome measureVitamin and mineral deficiencies and disorders extracted from the Defense Medical Epidemiology Database for the years 1997 to 2015
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date01/02/2019
Completion date13/06/2020

Eligibility

Participant type(s)Other
Age groupAdult
SexBoth
Target number of participantsAll 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 enrolment1382266
Key inclusion criteriaAll active-duty US military service members in the US Army, Navy, Air Force and Marines serving between 1997 and 2015
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment04/04/2019
Date of final enrolment30/08/2019

Locations

Countries of recruitment

  • United States of America

Study participating centre

US Army Research Institute of Environmental Medicine
10 General Greene Ave
Natick, MA
01760
United States of America

Sponsor information

US Army Research Institute of Environmental Medicine
Government

10 General Greene Ave
Natick
01760
United States of America

Phone +1 (0)4437523350
Email joseph.j.knapik.ctr@mail.mil
Website https://www.usariem.army.mil/
ROR logo "ROR" https://ror.org/00rg6zq05

Funders

Funder type

Government

U.S. Army Research Institute of Environmental Medicine
Government organisation / National government
Alternative name(s)
United States Army Research Institute of Environmental Medicine, USARIEM
Location
United States of America

Results and Publications

Intention to publish date01/01/2021
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planResults will be published in peer-reviewed journals and presented at scientific meetings.
IPD sharing planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 15/06/2021 26/10/2022 Yes No
Results article 01/08/2021 26/10/2022 Yes No

Editorial Notes

26/10/2022: Publication references added.
09/06/2020: The intention to publish date was changed from 18/12/2019 to 01/01/2021.
13/09/2019: Trial's existence confirmed by funder.