Randomised controlled trial of different energy formulas in healthy term infants: effects on later growth, body composition, bone health and cardiovascular?

ISRCTN	ISRCTN71531563
DOI	https://doi.org/10.1186/ISRCTN71531563
Secondary identifying numbers	N0012154277

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr MS Fewtrell
Scientific

Childhood Nutrition Research Centre
Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom

Phone	+44 (0)20 7242 9789 Ext 5585
Email	m.fewtrell@ich.ucl.ac.uk

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title	Randomised controlled trial of different energy formulas in healthy term infants: effects on later growth, body composition, bone health and cardiovascular?
Study objectives	Do differences in early energy intake and growth program fatness and other aspects of health during adolescence?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Neonatal Diseases
Intervention	Random Allocation (A) energy formula (B) standard; Cohort observation.
Intervention type	Other
Primary outcome measure	Body composition, bone mass, risk factors for cardiovascular disease (blood lipids, insulin) DXA
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/08/2004
Completion date	31/01/2006

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	Not provided at time of registration
Key inclusion criteria	Healthy term infants
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/08/2004
Date of final enrolment	31/01/2006

Childhood Nutrition Research Centre

London
WC1N 1EH
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

19/05/2017: No publications found in PubMed, verifying study status with principal investigator.