Condition category
Nutritional, Metabolic, Endocrine
Date applied
01/05/2020
Date assigned
15/06/2020
Last edited
15/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

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

https://www.udem.edu.mx/en

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

https://www.wur.nl/en/Research-Results/Chair-groups/Agrotechnology-and-Food-Sciences/Human-Nutrition-and-Health/Research/Nutrition-and-Health-over-the-Lifecourse.htm

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

Publication citations

Additional files

Editorial Notes

20/05/2020: Trial’s existence confirmed by the Research Ethics Committee of the University of Monterrey.