Condition category
Pregnancy and Childbirth
Date applied
08/12/2010
Date assigned
10/01/2011
Last edited
18/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ju.edu.et/jucan/

Contact information

Type

Scientific

Primary contact

Prof Henrik Friis

ORCID ID

Contact details

University of Copenhagen
Department of Human Nutrition
Rolighedsvej 30
Frederiksberg C.
1958
Denmark
hfr@life.ku.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Predictors of neonatal and early infant body composition and growth and its effect on health in Jimma, Ethiopia: an observational study of infant body composition using infant air displacement plethysmography

Acronym

iABC

Study hypothesis

The rationale for the study is that little is known about fat and lean mass development in foetal and early life, in particular in the studies population. Answering the following questions will provide new understanding of body composition in early life:
1. What are the fat and lean mass levels at birth?
2. Which maternal and infant factors predict neonatal body composition?
3. Which maternal and infant factors - including birth weight - predict changes in fat and lean mass from 0 to 6 months?
4. What is the relationship between birth weight and 6 month body composition?
5. What is the relationship between neonatal body composition and infant morbidity and growth?

Ethics approval

1. Jimma University Ethical Review Committee approved on the 23rd December 2008 (ref: RPO/56/2001) (Air Displacement Plethysmography Study)
2. Jimma University Ethical Review Committee approved on the 12th October 2009 (ref: RPGC/J05/2002) (Deuterium Dilution substudy)

N.B. The reference numbers are based on Ethiopian calendar, which is approximately 8 years behind Gregorian calendar

Study design

Observational cohort study with nested cross-sectional study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

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

Condition

Neonatal and infant fat and lean mass

Intervention

Neonatal and infant body composition is measured using infant air displacement plethysmography (PeaPod, Life Measurement, Inc). On a subsample of 120 individuals infant body composition is measured using deuterium dilution. Maternal body composition is measured using bio-impedance analysis (BC-418MA, Tanita B.V.). Anthropometry are measured using conventional methods, and questionnaire information is taken orally in local language.

The duration of the study is 6 months, as newborns and mothers are assessed 6 times: at birth, 6, 10, 14, 18 and 26 weeks of age. Duration of follow-up is also 6 months.

Contact details for Ethiopian Principal Investigator:
Dr Tsinuel Girma
Department of Pediatrics and Child Health
P.O.BOX 574
Jimma
Ethiopia

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Fat and lean mass at birth, 6-, 10-, 14-, 18- and 26 weeks of age, measured with infant air displacement plethymography and deuterium dilution (in a sub-sample)

Secondary outcome measures

Anthropometry and self-reported (by the mother) morbidity at birth, 6-, 10-, 14-, 18- and 26 weeks of age

Overall trial start date

17/12/2008

Overall trial end date

01/01/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pregnant mother aged between 15 - 45 years
2. Currently living in Jimma town
3. Planning to stay in Jimma town for at least 6 months after birth
4. Consent is given
5. Children are between 0 - 6 months of age

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

350

Participant exclusion criteria

1. Birth weight less than 1500 g
2. Congenital malformation

Recruitment start date

17/12/2008

Recruitment end date

01/01/2012

Locations

Countries of recruitment

Ethiopia

Trial participating centre

University of Copenhagen
Frederiksberg C.
1958
Denmark

Sponsor information

Organisation

University of Copenhagen (Denmark)

Sponsor details

Nørregade 10
Copenhagen
DK-1017
Denmark
+45 35 32 26 26
ku@ku.dk

Sponsor type

University/education

Website

http://ku.dk

Funders

Funder type

Industry

Funder name

Danida (Denmark)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University of Copenhagen (Denmark) - Faculty of Life Sciences

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23985805

Publication citations

  1. Results

    Andersen GS, Girma T, Wells JC, Kæstel P, Leventi M, Hother AL, Michaelsen KF, Friis H, Body composition from birth to 6 mo of age in Ethiopian infants: reference data obtained by air-displacement plethysmography., Am. J. Clin. Nutr., 2013, 98, 4, 885-894, doi: 10.3945/ajcn.113.063032.

Additional files

Editorial Notes