Effectiveness of coconut oil in the control of pediculosis capitis in preschoolers in Acapulco, Guerrero, Mexico

ISRCTN	ISRCTN75546816
DOI	https://doi.org/10.1186/ISRCTN75546816
Secondary identifying numbers	ECOPC-CIET-PT

Submission date: 04/11/2016
Registration date: 08/11/2016
Last edited: 25/05/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Pediculosis capitis, more commonly referred to as head lice, is a common problem among children in Acapulco, Mexico. Although not a life-threatening condition, a head lice infection can cause great distress through discomfort and the negative associations people have with head lice. Insecticides (chemicals which kill insects) are the most common treatment for head lice. The overuse of these chemicals has led to the development of lice which are resistant, and can survive even after the application of chemicals. In recent years, there have been many attempts to develop alternative treatments at a low cost. Acapulco has a nearby coastal strip where coconut palms are grown and from which oil can be extracted for different uses, such as for skin moisturisation and sunscreen. The aim of this study is to investigate the effectiveness of coconut oil as a treatment for head lice in children attending kindergartens in Acapulco.

Who can participate?
Children attending a participating kindergarten aged between four and six years old.

What does the study involve?
Participating kindergartens are randomly allocated to one of two groups. In kindergartens in the first group, children have 30ml coconut oil applied onto their scalp, which is repeated 10 days later. In kindergartens in the second group, children continue as normal and have no additional treatment applied. At the start of the study and then seven days after those in the first group have had their final application of coconut oil, in both groups, children’s scalps are inspected for head lice.

What are the possible benefits and risks of participating?
Participants who receive the treatment benefit from receiving treatment free of charge that they would otherwise not have received. There are no risks associated with participating.

Where is the study run from?
Eight schools in Acapulco (Mexico)

When is the study starting and how long is it expected to run for?
July 2012 to August 2016

Who is funding the study?
Universidad Autónoma de Guerrero (Mexico)

Who is the main contact?
1. Dr Sergio Paredes-Solís (scientific)
srgprds@gmail.com
2. Mrs Janet Saldaña-Almazán (public)
janetsaldana22@hotmail.com

Contact information

Dr Sergio Paredes-Solís
Scientific

Centro de Investigación de Enfermedades Tropicales
Universidad Autónoma de Guerrero
Calle Pino S/N
Colonia El Roble
Acapulco
39640
Mexico

ORCID ID	0000-0002-3015-3038
Phone	+52 74 49 09 46 82
Email	srgprds@gmail.com

Mrs Janet Saldaña-Almazán
Scientific

Centro de Investigación de Enfermedades Tropicales
Universidad Autónoma de Guerrero
Calle Pino s/n
Colonia El Roble
Acapulco
39640
Mexico

ORCID ID	0000-0003-0039-6642
Phone	+52 74 41 32 88 50
Email	janetsaldana22@hotmail.com

Study information

Study design	Cluster randomized controlled trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	School
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Effectiveness of coconut oil in the control of pediculosis capitis in preschoolers in Acapulco, Guerrero, Mexico: A pilot randomized controlled cluster trial
Study acronym	ECOPC-CIET-PT
Study objectives	Coconut oil is effective as a topical treatment for pediculosis capitis in preschoolers.
Ethics approval(s)	Ethics Committee Research Center for Tropical Diseases at the Autonomous University of Guerrero, ref: 2015-005
Health condition(s) or problem(s) studied	Pediculosis capitis
Intervention	Eight kindergarten's from zone 20 of the Ministry of Education of Guerrero, Acapulco city, are randomised to one of two groups using a computerised random number generator (www.random.org). At baseline, an initial measurement will be undertaken to estimate the prevalence of pediculosis capitis in each of the kindergartens. This involves a short questionnaire answered by the children's parents, the provision information about the study and provision of informed consent. Intervention group: Following collection of the baseline measurement, students have 30 ml of coconut oil applied onto their scalp, which is repeated 10 days later. Control group: Participants do not receive any treatment and continue as normal. Follow up for all participants involves measuring the rate of pediculosis capitis infestation throughout direct inspection of the scalp at each kindergarten one week later of the last visit to the intervention schools (day 17)
Intervention type	Other
Primary outcome measure	Pediculosis capitis infestation rate in school children is measured by direct observation in eight areas of 2x2cm on the scalp of each student, at baseline and 17 days.
Secondary outcome measures	Pediculosis capitis infestation level in school children is measured by direct observation in eight areas of 2x2cm on the scalp of each student, at baseline and 17 days.
Overall study start date	22/08/2014
Completion date	27/05/2016

Eligibility

Participant type(s)	Other
Age group	Child
Lower age limit	4 Years
Upper age limit	6 Years
Sex	Both
Target number of participants	Total participants 600, 8 clusters with aproximately 75 children per cluster
Key inclusion criteria	1. Children attending school the day of the survey 2. Age between four and six years
Key exclusion criteria	Preschoolers with serious illnesses such as cancer, immune disease or disability.
Date of first enrolment	25/01/2015
Date of final enrolment	15/03/2015

Locations

Countries of recruitment

Mexico

Study participating centres

Jose Antonio Adame School

Paseo de la Cañada s/n
Colonia Alta Progreso
Acapulco
39610
Mexico

Educadora Guerrerense School

Paseo de la comunidad s/n
Colonia Módulo Social Fovisste
Acapulco
39500
Mexico

Teresa Gaminde School

Campeche s/n
Colonia Progreso
Acapulco
39350
Mexico

2 de Febrero School

Calle Libertad de Expresión s/n
Colonia Los Periodistas
Acapulco
39613
Mexico

Aaron M. Flores School

Calle Paseo de la Cañada s/n
Colonia Alta Progreso
Acapulco
39610
Mexico

Rubén Darío School

Calle 2 s/n
Colonia Ampliación Palma Sola
Acapulco
39510
Mexico

Vicente Guerrero School

Avenida División del Norte s/n
Colonia Francisco Villa
Acapulco
39610
Mexico

Independencia de México School

Avenida 16 de Septiembre s/n
Colonia 13 de Junio
Acapulco
39350
Mexico

Sponsor information

Universidad Autónoma de Guerrero
University/education

Av, Javier Mendez Aponto 1
Fracc. Servidor Agrario
Chilpancingo, Gro.
39070
Mexico

Phone	+52 747 471 9310
Email	sparedes@uagro.mx
Website	https://www.uagro.mx/
"ROR"	https://ror.org/054tbkd46

Funders

Funder type

University/education

Universidad Autónoma de Guerrero

No information available

Results and Publications

Intention to publish date	21/07/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication of study results in a peer reviewed journal.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Lic. Janet Saldaña-Almazán (janetsaldana22@hotmail.com) or Dr. Sergio Paredes-Solís (srgprds@gmail.com)

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Basic results		10/05/2017	25/05/2017	No	No

Additional files

ISRCTN75546816_BasicResults_10May17.docx: Uploaded 25/05/2017

Editorial Notes

25/05/2017: Results summary uploaded.