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 |
| Protocol serial number | N0012154277 |
| Sponsor | Department of Health |
| Funder | Great Ormond Street Hospital for Children NHS Trust / Institute of Child Health (UK) |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 19/05/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
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
Contact information
Dr MS Fewtrell
Scientific
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 |
|---|---|
| m.fewtrell@ich.ucl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Body composition, bone mass, risk factors for cardiovascular disease (blood lipids, insulin) DXA |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Childhood Nutrition Research Centre
London
WC1N 1EH
United Kingdom
WC1N 1EH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
19/05/2017: No publications found in PubMed, verifying study status with principal investigator.
