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Mercurius 5 years follow-up study

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28614
Enrollment
230
Registered
2015-12-21
Start date
2016-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy infants

Interventions

None listed

Sponsors

Nutricia Research
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Key outcome: Body Mass Index (BMI) at 3, 4, and 5 years of age

Secondary

MeasureTime frame
- 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

Contacts

Public ContactAnneke Ravensbergen

Nutricia Research

Anneke.ravensbergen@danone.com+31(30) 209 5000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)