A safety and growth study with a new fat blend.

A randomised, controlled, double-blind trial to investigate the effects of a new infant formula on growth, tolerance and safety in healthy term infants.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21391

Enrollment

313

Registered

2012-11-02

Start date

2012-09-16

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 term infants

Interventions

Duration of intervention: 13-17 weeks. Intervention group: Standard infant formula containing the new fat blend. Control group: Standard infant formula containing the standard fat blend. Reference

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy term (gestational age >= 37 1/7 and <= 42 6/7 weeks); 2. Age <= 35 days (preferably as soon as possible after birth); 3. Birth weight within normal range (10th to 90th percentile); 4. Exclusively formula fed (mothers who have chosen not to breastfeed or mothers who ended breastfeeding by time of inclusion); OR Exclusively breastfed (mothers willing to exclusively breastfeed at least till 13 weeks of age (and preferably till 17 weeks of age); 5. Written informed consent from parent(s) and/or legal guardian, aged ≥ 18 years.

Exclusion criteria

Exclusion criteria: 1. Known current or previous illnesses/conditions or intervention which could interfere with the study or its outcome parameters; 2. Mother known to suffer from hepatitis B or human immunodeficiency virus (HIV) with a minimum number of formula fed infants ≤ 14 days 3. Need to be fed with a special diet other than standard (non hydrolysed) cow¡®s milk-based infant formula; 4. Currently participating or have participated in any other study involving investigational or marketed products; 5. Incapability of the parent(s) to comply with study protocol or investigator's uncertainty about the willingness or ability of the parent(s) to comply with the protocol requirements.

Design outcomes

Primary

Measure	Time frame
To investigate equivalence of weight gain from randomisation until the age of 17 weeks.	—

Secondary

Measure	Time frame
1. To investigate equivalence of other growth parameters until the age of 17 weeks. 2. To assess gastrointestinal tolerance and safety until the age of 17 weeks. 3.To investigate efficacy in weight gain at 12 months	—

Contacts

Public ContactDanone Nutricia Research

Nutricia Research BV PO Box 80141

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)