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Mercurius 5 years follow-up study


- candidate number23510
- NTR NumberNTR5538
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-dec-2015
- Secondary IDsEPI1.C.C Nutricia Research 
- Public TitleMercurius 5 years follow-up study
- Scientific TitleA follow-up study of a randomised, controlled, double-blind study to investigate the effects of a new infant formula given in the first 4 months of life on growth and body composition up to 5 years of age
- ACRONYMMercurius 5 year FU
- hypothesisThe infant formula containing a new fat blend, consumed in the first 4 months of life, will have a positive effect on the growth trajectory in toddlerhood up to 5 years of age.
- Healt Condition(s) or Problem(s) studiedHealthy children
- Inclusion criteria- Subjects that participated in the original Mercurius study (NTR3683) up to visit 5 (approx. 4 months of age) are eligible for this follow up study.
- Written Informed Consent
- Exclusion criteria- Investigator's uncertainty about the willingness or ability of the child and parents to comply with the protocol requirements.
- Subjects that were recruited by investigators who decided not to participate in the 5 year follow up study.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-jan-2016
- planned closingdate28-feb-2019
- Target number of participants230
- InterventionsN/A
- Primary outcomeKey outcome: Body Mass Index (BMI) at 3, 4, and 5 years of age
- Secondary outcome- Prevalence of overweight and obesity at 3, 4, and 5 years of age
- Sum of skin fold thicknesses at 3, 4, and 5 years of age
- Percentage total body fat (derived from skinfolds)
- Head- and waist- circumference at 3, 4, and 5 years of age
- TimepointsVisit at 3, 4 and 5 years of age. Phone call at 3.5 and 4.5 years of age
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES Anneke Ravensbergen
- CONTACT for SCIENTIFIC QUERIESMSc. S. Schoen
- Sponsor/Initiator Nutricia Research BV
- Funding
(Source(s) of Monetary or Material Support)
Nutricia Research - Centre for Specialised Nutrition
- Publications
- Brief summaryThe present study is a follow up study of the original Mercurius study (NTR3683) at the age of 3-5 years. The main objective of this study is to gain insight into the possible long-term effects, up to 5 years of age, on growth and body composition development in subjects who have received the test product compared to subjects who have received the control product in the first 4 months of age and in comparison to the breastfed reference group. Study visits will take place at 3, 4 and 5 years of age. A phone call will take place at 3.5 and 4.5 years of age.
- Main changes (audit trail)
- RECORD21-dec-2015 - 31-jan-2016


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