Condition category
Infections and Infestations
Date applied
04/11/2016
Date assigned
08/11/2016
Last edited
25/05/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Sergio Paredes-Solís

ORCID ID

http://orcid.org/0000-0002-3015-3038

Contact details

Centro de Investigación de Enfermedades Tropicales
Universidad Autónoma de Guerrero
Calle Pino S/N
Colonia El Roble
Acapulco
39640
Mexico
+52 74 49 09 46 82
srgprds@gmail.com

Type

Scientific

Additional contact

Mrs Janet Saldaña-Almazán

ORCID ID

http://orcid.org/0000-0003-0039-6642

Contact details

Centro de Investigación de Enfermedades Tropicales
Universidad Autónoma de Guerrero
Calle Pino s/n
Colonia El Roble
Acapulco
39640
Mexico
+52 74 41 32 88 50
janetsaldana22@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ECOPC-CIET-PT

Study information

Scientific title

Effectiveness of coconut oil in the control of pediculosis capitis in preschoolers in Acapulco, Guerrero, Mexico: A pilot randomized controlled cluster trial

Acronym

ECOPC-CIET-PT

Study hypothesis

Coconut oil is effective as a topical treatment for pediculosis capitis in preschoolers.

Ethics approval

Ethics Committee Research Center for Tropical Diseases at the Autonomous University of Guerrero, ref: 2015-005

Study design

Cluster randomized controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Schools

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

22/08/2014

Overall trial end date

27/05/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Children attending school the day of the survey
2. Age between four and six years

Participant type

Other

Age group

Child

Gender

Both

Target number of participants

Total participants 600, 8 clusters with aproximately 75 children per cluster

Participant exclusion criteria

Preschoolers with serious illnesses such as cancer, immune disease or disability.

Recruitment start date

25/01/2015

Recruitment end date

15/03/2015

Locations

Countries of recruitment

Mexico

Trial participating centre

Jose Antonio Adame School
Paseo de la Cañada s/n Colonia Alta Progreso
Acapulco
39610
Mexico

Trial participating centre

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

Trial participating centre

Teresa Gaminde School
Campeche s/n Colonia Progreso
Acapulco
39350
Mexico

Trial participating centre

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

Trial participating centre

Aaron M. Flores School
Calle Paseo de la Cañada s/n Colonia Alta Progreso
Acapulco
39610
Mexico

Trial participating centre

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

Trial participating centre

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

Trial participating centre

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

Sponsor information

Organisation

Universidad Autónoma de Guerrero

Sponsor details

Av
Javier Mendez Aponto 1
Fracc. Servidor Agrario
Chilpancingo
Gro.
39070
Mexico
+52 747 471 9310
sparedes@uagro.mx

Sponsor type

University/education

Website

https://www.uagro.mx/

Funders

Funder type

University/education

Funder name

Universidad Autónoma de Guerrero

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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)

Intention to publish date

21/07/2017

Participant level data

Available on request

Results - basic reporting

See additional file ISRCTN75546816_BasicResults_10May17

Publication summary

Publication citations

Additional files

Editorial Notes

25/05/2017: Results summary uploaded.