Condition category
Not Applicable
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

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



Primary contact

Dr Mark Manary


Contact details

7435 Flora Avenue
St. Louis
United States of America

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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


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, ref: P.05/08/669
2. Human Research Protection Office of Washington University in St. Louis, 31/03/2011, ref: 201103423
3. Johns Hopkins School of Medicine Institutional Review Board, 14/05/2015, ref: IRB00070244

Study design

Observational cross-sectional study

Primary study design


Secondary study design

Cross sectional study

Trial setting


Trial type


Patient information sheet

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


Childhood stunting


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.

Added 15/09/2017:
The clinical aspects of the trial were completed as described in the original application. Subjects were recruited and participation was in accordance with initial registry information. Testing choline and choline metabolite levels were done as described. Upon testing the children's serum for choline and the emergence of interesting findings, it was decided that untargeted metabolite testing would be useful and informative. The original laboratory testing was targeted, the methods used for untargeted are the same, but this approach allows for discovery of metabolites that were not anticipated. Therefore the trial now includes targeted and untargeted testing of serum metabolites in the same population of Malawian children with varying degrees of environmental enteropathy.

Intervention type



Drug names

Primary outcome measure

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


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

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

Participant type

Healthy volunteer

Age group




Target number of participants


Participant exclusion criteria

Chronically ill or acutely malnourished

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

University of Malawi
College of Medicine
Blantyre 3

Sponsor information


Johns Hopkins University (USA)

Sponsor details

400 N. Broadway
United States of America

Sponsor type




Funder type


Funder name

National Institutes of Health

Alternative name(s)

The National Institutes of Health, NIH

Funding Body Type

government organisation

Funding Body Subtype

National government


United States of America

Funder name

Hickey Family Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Children's Discovery Institute

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations


United States of America

Results and Publications

Publication and dissemination plan

The publication/dissemination plan is to complete the metabolomic analyses by July 2018 and publish these results in a peer reviewed journal by December 2018.

IPD sharing statement
The subject level data for the metabolic analyses will be available as a supplement to the peer reviewed article. Until that time the subject level data will be held by the principal investigators.

Intention to publish date


Participant level data


Basic results (scientific)

Publication list

2016 results in:

Publication citations

Additional files

Editorial Notes

15/09/2017: Interventions, publication and dissemination plan updated. 09/06/2016: Publication reference added.