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
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, 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
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 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.
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
Other
Phase
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
01/08/2008
Overall trial end date
01/01/2013
Reason abandoned (if study stopped)
Eligibility
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
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
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
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
01/12/2018
Participant level data
Other
Basic results (scientific)
Publication list
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27281303