Plain English Summary
Background and study aims
Major depressive disorder (MDD) and Iron deficiency anemia are two of the three main causes of disability among adolescents worldwide. Additionally, iron plays an important role in the synthesis of neurotransmitters (signaling chemicals found in the brain and nervous system) and in neurological development.
The aim of this study is to examine the association of anemia and iron deficiency with depressive symptoms and self-harm behavior in Mexican adolescent girls.
Who can participate?
Girls aged 12 to 19 years old, who live in urban areas in Northern Mexico
What does the study involve?
Participants will be assessed for anthropocentric measures, pubertal development, hemoglobin levels and iron status (from blood samples), as well as depressive symptoms and self-harm behavior.
What are the possible benefits and risks of participating?
Participants will receive a report of their nutritional status and iron status. At the end of the study participants receive nutritional recommendations and the opportunity to have a free psychological evaluation. This study is not thought to be associated with increased health risks. However, blood drawing occasionally can cause bruising.
Where is the study run from?
Universidad de Monterrey (Mexico)
When is the study starting and how long is it expected to run for?
From September 2018 to March 2019
Who is funding the study?
Universidad de Monterrey (Mexico)
Who is the main contact?
Dr Ana Carla Cepeda-Lopez
ana.cepeda@udem.edu
Trial website
Contact information
Type
Scientific
Primary contact
Dr Ana Carla Cepeda-Lopez
ORCID ID
http://orcid.org/0000-0002-3935-3917
Contact details
Av. Ignacio Morones Prieto 4500 poniente
Col. Jesús M. Garza
San Pedro Garza García
Nuevo León
San Pedro Garza García
66238
Mexico
+52 (81) 8215-1000
ana.cepeda@udem.edu
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Investigation of the iron status and presence of depressive symptoms and self-harm behavior, and the possible interaction of this association with the gut microbiota, intestinal inflammation and pubertal development in adolescent girls living in Mexico
Acronym
DBM ADOL
Study hypothesis
Iron deficiency in Mexican adolescents may be associated with the presence of depressive symptoms and self-harm behavior.
Ethics approval
Approved 04/07/2018, the Research Ethics Committee of the University of Monterrey (Av. Morones Prieto 4500 Pte, San Pedro Garza Gacia, Nuevo Leon, Mexico 66238; +52 (81) 8215 1212), ref: 04072018-CEI
Study design
Cross-sectional observational study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Schools
Trial type
Screening
Patient information sheet
No participant information sheet available
Condition
Iron deficiency and depressive symptoms
Intervention
Adolescent girls aged 12 to 19 inclusive from public schools were recruited. Written consent was obtained from the adolescents and their parents. The assessment and samples were taken within one visit.
Blood samples were drawn by a trained nurse or a technician in order to assess iron status (SF, BIS and sTfR), and inflammation (CRP, AGP) biomarkers. The serum samples were exported to Germany, where iron and inflammation biomarkers were measured using in-house sandwich enzyme-linked immunosorbent assay in the Vitmin Lab, Germany.
The Six-item Kutcher Adolescent Depression Scale (6-KADS) (LeBlanc, et al., 2002) was used to identify if the adolescent has symptoms of depression. The 6-KADS was developed to assist in the public health and clinical identification of young people at risk for depression.
Intervention type
Other
Phase
Drug names
Primary outcome measure
All outcome measures were assessed at a single timepoint.
1. Serum ferritin level measured using in-house sandwich enzyme-linked immunosorbent assay of serum samples
2. Serum transferrin receptor level measured using in-house sandwich enzyme-linked immunosorbent assay of serum samples
3. Depressive symptoms score assessed by the Six-item Kutcher Adolescent Depression Scale (6-KADS)
Secondary outcome measures
1. Anemia measured using a Hemocue 201+ portable photometer apparatus to assess hemoglobin in capillary blood
2. Gut microbiota composition in fecal samples assessed by 16s rRNA sequencing. This analysis is on hold as the Microbiology Lab of Wageningen University has suspended activities due to COVID-19.
Overall trial start date
07/04/2016
Overall trial end date
08/03/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adolescent girls aged 12 to 19 inclusive attending public schools.
2. Written consent from the parents or legal guardians
3. Written consent from the adolescents
4. Considered to be in good health
Participant type
Healthy volunteer
Age group
Other
Gender
Female
Target number of participants
450 was the target. However, we were able to recruit only 408
Total final enrolment
408
Participant exclusion criteria
1. Diagnosis of chronic disease that may affect iron status.
2. History of major surgery in the last month (at the moment of recruitment).
3. Regular use of antibiotics.
Recruitment start date
04/09/2018
Recruitment end date
08/03/2019
Locations
Countries of recruitment
Mexico
Trial participating centre
Universidad de Monterrey
Av. Ignacio Morones Prieto 4500 poniente
Col. Jesús M. Garza
San Pedro Garza García
Nuevo León, México
San Pedro Garza, Garcia
66238
Mexico
Sponsor information
Organisation
Universidad de Monterrey
Sponsor details
Av. Ignacio Morones Prieto 4500 poniente
Col. Jesús M. Garza
San Pedro Garza García
Nuevo León
San Pedro Garza Garcia
66238
Mexico
+52 (81) 8215 1000
investigacion@udem.edu
Sponsor type
University/education
Website
Organisation
Wageningen University & Research
Sponsor details
Stippeneng 4
Wageningen
6708WE
Netherlands
+31 06 7 480 080
office.hn@wur.nl
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Universidad de Monterrey (UDEM)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Consejo Nacional de Ciencia y Tecnología (National Council of Science and Technology, Mexico)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
1. Iron Status Assessment in a setting of inflammation (intended date of publication summer 2020)
2. Iron Status and Depressive Symptoms (intended date of publication summer-fall 2020)
3. The role of gut microbiota composition on depressive symptoms (intended date of publication to be confirmed)
IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. Datasets will be shared under request with the reviewers for publication purposes. The use of the datasets generated during this study by a third party can be possible only if Universidad de Monterrey and Wageningen University agree.
Intention to publish date
01/11/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list