Condition category
Not Applicable
Date applied
26/04/2016
Date assigned
27/04/2016
Last edited
10/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Choline is an essential nutrient, required for many basic metabolic processes in the human body. Children in Africa are often stunted, or poorly grown. Nothing is known about the relationship between growth and the amount of choline in this population. This study will determine whether children who are poorly grown have lower or higher choline levels in their blood.

Who can participate?
Healthy children aged 6 months to 5 years resident in one of 5 rural Malawian villages

What does the study involve?
Participants have their length and weight measured, answer questions about their household living situation, and have their blood tested for choline and two choline breakdown products.

What are the possible benefits and risks of participating?
There is no benefit of participation for these children. The benefit to society is that something will be learned about choline and growth which may be used to help other children in the future. All of the data are made anonymous before analysis. There is only a minimal risk of discomfort to the participants, as they are receiving no interventions of any kind.

Where is the study run from?
University of Malawi (Malawi)

When is the study starting and how long is it expected to run for?
August 2008 to January 2013

Who is funding the study?
1. National Institutes of Health (USA)
2. Hickey Family Foundation (USA)
3. Children's Discovery Institute (USA)

Who is the main contact?
Dr Mark Manary

Trial website

Contact information

Type

Public

Primary contact

Dr Mark Manary

ORCID ID

Contact details

7435 Flora Avenue
St. Louis
63143
United States of America

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Serum choline with linear growth failure in young children from rural Malawi

Acronym

Study hypothesis

Low serum choline concentrations and higher betaine/choline and TMAO/choline ratios would be associated with linear growth failure in young children.

Ethics approval

1. College of Medicine Research Ethics Committee of the University of Malawi, 07/03/2011, P.05/08/669
2. Human Research Protection Office of Washington University in St. Louis, 31/03/2011, 201103423
3. Johns Hopkins School of Medicine Institutional Review Board, 14/05/2015, IRB00070244

Study design

Observational cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Community

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Childhood stunting

Intervention

At a single point in time this group of 325 children will have data regarding their height, weight and some basic demographic characteristics collected and a blood sample analyzed for 3 metabolites, choline, betaine and trimethylene N-oxide. These data will be analyzed to see if there is a relationship between the body size measurements and these metabolites in blood.

Intervention type

Not Specified

Phase

Drug names

Primary outcome measures

Serum choline, betaine and TMAO measured on the single day when the subject was encountered and tested. There is no follow-up.

Secondary outcome measures

Correlations between linear growth and choline, betaine and TMAO levels measured on the single day when the subject was encountered and tested. There is no follow-up.

Overall trial start date

01/08/2008

Overall trial end date

01/01/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Well children aged 6 months to 5 years resident in one of 5 rural Malawian villages

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

325

Participant exclusion criteria

Chronically ill or acutely malnourished

Recruitment start date

01/08/2008

Recruitment end date

01/01/2012

Locations

Countries of recruitment

Malawi

Trial participating centre

University of Malawi
College of Medicine
Blantyre 3
Malawi

Sponsor information

Organisation

Johns Hopkins University (USA)

Sponsor details

400 N. Broadway
Baltimore
21287
United States of America

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institutes of Health

Alternative name(s)

NIH

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Funder name

Hickey Family Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Children's Discovery Institute

Alternative name(s)

CDI

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United States of America

Results and Publications

Publication and dissemination plan

Publish in peer-reviewed journal

Intention to publish date

01/01/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27281303

Publication citations

Additional files

Editorial Notes

09/06/2016: Publication reference added.