Contact information
Type
Scientific
Primary contact
Dr MS Fewtrell
ORCID ID
Contact details
Childhood Nutrition Research Centre
Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
+44 (0)20 7242 9789 Ext 5585
m.fewtrell@ich.ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0012154277
Study information
Scientific title
Randomised controlled trial of different energy formulas in healthy term infants: effects on later growth, body composition, bone health and cardiovascular?
Acronym
Study hypothesis
Do differences in early energy intake and growth program fatness and other aspects of health during adolescence?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Neonatal Diseases
Intervention
Random Allocation (A) energy formula (B) standard; Cohort observation.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Body composition, bone mass, risk factors for cardiovascular disease (blood lipids, insulin) DXA
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/08/2004
Overall trial end date
31/01/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy term infants
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/08/2004
Recruitment end date
31/01/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Childhood Nutrition Research Centre
London
WC1N 1EH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health (UK)
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