The double burden of malnutrition in Mexican adolescents

ISRCTN ISRCTN65337024
DOI https://doi.org/10.1186/ISRCTN65337024
Submission date
01/05/2020
Registration date
15/06/2020
Last edited
15/09/2022
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
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

Contact information

Dr Ana Carla Cepeda-Lopez
Scientific

Av. Ignacio Morones Prieto 4500 poniente
Col. Jesús M. Garza
San Pedro Garza García
Nuevo León
San Pedro Garza García
66238
Mexico

ORCiD logoORCID ID 0000-0002-3935-3917
Phone +52 (81) 8215-1000
Email ana.cepeda@udem.edu

Study information

Study designCross-sectional observational study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)School
Study typeScreening
Participant information sheet No participant information sheet available
Scientific titleInvestigation 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
Study acronymDBM ADOL
Study objectivesIron deficiency in Mexican adolescents may be associated with the presence of depressive symptoms and self-harm behavior.
Ethics approval(s)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
Health condition(s) or problem(s) studiedIron deficiency and depressive symptoms
InterventionAdolescent 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 typeOther
Primary outcome measureAll 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 measures1. 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 study start date07/04/2016
Completion date08/03/2019

Eligibility

Participant type(s)Healthy volunteer
Age groupOther
SexFemale
Target number of participants450 was the target. However, we were able to recruit only 408
Total final enrolment408
Key inclusion criteria1. 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
Key exclusion criteria1. 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.
Date of first enrolment04/09/2018
Date of final enrolment08/03/2019

Locations

Countries of recruitment

  • Mexico

Study 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

Universidad de Monterrey
University/education

Av. Ignacio Morones Prieto 4500 poniente
Col. Jesús M. Garza
San Pedro Garza García
Nuevo León
San Pedro Garza Garcia
66238
Mexico

Phone +52 (81) 8215 1000
Email investigacion@udem.edu
Website https://www.udem.edu.mx/en
Wageningen University & Research
University/education

Funders

Funder type

University/education

Universidad de Monterrey (UDEM)

No information available

Consejo Nacional de Ciencia y Tecnología (National Council of Science and Technology, Mexico)

No information available

Results and Publications

Intention to publish date01/11/2020
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryPublished as a supplement to the results publication
Publication and dissemination plan1. 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 planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article 18/05/2022 15/09/2022 Yes No

Editorial Notes

15/09/2022: Publication reference added.
20/05/2020: Trial’s existence confirmed by the Research Ethics Committee of the University of Monterrey.