Research with human participants

Overview of medical research in the Netherlands

MERCURIUS 5 years Follow-Up: a 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

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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 of an infant formula containing a new fat blend given in the first 4 months of life

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Other condition
Study type
Observational non invasive

ID

NL-OMON42552

Source

ToetsingOnline

Brief title

MERCURIUS 5 years Follow-Up study

Condition

  • Other condition

Synonym

Effects on growth

Health condition

effect op groei

Research involving

Human

Sponsors and support

Primary sponsor :
Nutricia Research
Source(s) of monetary or material Support :
Nutricia Research

Intervention

Keyword :
Effect on growth, Follow-up study, Healthy infants, New infant formula, up to 5 years of age

Outcome measures

Primary outcome

Key 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

Background summary

The present study is a follow up study of the original Mercurius study
(NTR3683) at the age of 3-5 years.

Study objective

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 of an
infant formula containing a new fat blend given in the first 4 months of life

Study design

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.

Intervention

nvt

Study burden and risks

In the present study no product intervention is given. In addition, no invasive
assessments are performed. Therefore, no risks are expected from participation
in this study.

Public
Nutricia Research

Uppsalalaan 12
Utrecht 3584 CT
NL
Scientific
Nutricia Research

Uppsalalaan 12
Utrecht 3584 CT
NL

Listed location countries

Netherlands

Age

Children (2-11 years)

Inclusion criteria

- Participation in the Mercurius study (NTR3683) up to visit 5 (4 months of age)
- Written informed consent from parent(s) or legally acceptable representative(s)

Exclusion criteria

- The Investigator's uncertainty about the willingness or ability of the child and parents to comply with the protocol requirements
- Subjects of the Mercurius study (NTR3683) whose Principle Investigator chose not participate in the Mercurius 5 years Follow-Up study

Design

Study type :
Observational non invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
100
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
IRB Nijmegen: Independent Review Board Nijmegen (Wijchen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
IRB Nijmegen: Independent Review Board Nijmegen (Wijchen)
Not approved
Date :
Application type :
Amendment
Review commission :
IRB Nijmegen: Independent Review Board Nijmegen (Wijchen)
Approved WMO
Date :
Application type :
Amendment
Review commission :
IRB Nijmegen: Independent Review Board Nijmegen (Wijchen)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL54365.072.15