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

ISRCTN ISRCTN14597012
DOI https://doi.org/10.1186/ISRCTN14597012
Secondary identifying numbers N/A
Submission date
26/04/2016
Registration date
27/04/2016
Last edited
19/05/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Mark Manary
Public

7435 Flora Avenue
St. Louis
63143
United States of America

Study information

Study designObservational cross-sectional study
Primary study designObservational
Secondary study designCross sectional study
Study setting(s)Community
Study typeOther
Participant information sheet Not available in web format, please use the contact details to request a patient information sheet
Scientific titleSerum choline with linear growth failure in young children from rural Malawi
Study objectivesLow serum choline concentrations and higher betaine/choline and TMAO/choline ratios would be associated with linear growth failure in young children.
Ethics approval(s)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
Health condition(s) or problem(s) studiedChildhood stunting
InterventionAt 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 typeOther
Primary outcome measureSerum choline, betaine and TMAO measured on the single day when the subject was encountered and tested. There is no follow-up.
Secondary outcome measuresCorrelations 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 study start date01/08/2008
Completion date01/01/2013

Eligibility

Participant type(s)Healthy volunteer
Age groupChild
Lower age limit6 Months
Upper age limit5 Years
SexBoth
Target number of participants325
Total final enrolment325
Key inclusion criteriaHealthy children aged 6 months to 5 years resident in one of 5 rural Malawian villages
Key exclusion criteriaChronically ill or acutely malnourished
Date of first enrolment01/08/2008
Date of final enrolment01/01/2012

Locations

Countries of recruitment

  • Malawi

Study participating centre

University of Malawi
College of Medicine
Blantyre 3
Malawi

Sponsor information

Johns Hopkins University (USA)
University/education

400 N. Broadway
Baltimore
21287
United States of America

ROR logo "ROR" https://ror.org/00za53h95

Funders

Funder type

Government

National Institutes of Health
Government organisation / National government
Alternative name(s)
Institutos Nacionales de la Salud, US National Institutes of Health, NIH
Location
United States of America
Hickey Family Foundation

No information available

Children's Discovery Institute
Private sector organisation / Other non-profit organizations
Alternative name(s)
CDI
Location
United States of America

Results and Publications

Intention to publish date01/12/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryOther
Publication and dissemination planThe 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 planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/07/2016 Yes No
Results article 25/10/2017 19/05/2023 Yes No

Editorial Notes

19/05/2023: Publication reference and total final enrolment added.
15/09/2017: Interventions, publication and dissemination plan updated.
09/06/2016: Publication reference added.