Clinical trial NCT01609634: New Infant Formula Trial in Healthy Term Subjects on Growth, Body Composition, Tolerance and Safety
Official title: A Randomised, Controlled, Double-blind Trial to Investigate the Effects of a New Infant Formula in Healthy Term Subjects on Growth, Body Composition, Tolerance and Safety.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Healthy
Term infants
Growth
Body composition
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Nutricia Research
First posted: 2012-06-01
Enrollment: 541
Sex: ALL
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is initiated to investigate the effect of a new infant formula in healthy term subjects on growth, body composition, tolerance and safety.

Detailed description: This is a "best after breast design" to measure the effect of this new infant formula in healthy term subjects on growth, body composition, tolerance and safety including immune status, gut microbiota, and early indicators (markers) of disease. These markers will be explored if they could predict the risk of eczema and other allergic disease, and to evaluate if these markers are influenced by early nutrition.

Eligibility criteria: Inclusion Criteria:

1. Healthy term infants (gestational age ≥ 37 and ≤ 42 weeks)
2. Age ≤ 28 days
3. Birth weight within normal range for gestational age and sex (3rd to 90th percentile according to applicable growth charts)
4. Head circumference at birth within normal range (3rd to 90th percentile of the chart)
5. Chinese, Malay, or Indian ethnicity
6. Written informed consent from parent(s)
7. Currently reside in Singapore and with the intention to reside in Singapore for at least the next 2 years

Exclusion criteria for the pregnant women/parents:

1. Pregnant women / mothers who are currently participating or will participate in any other (clinical) study involving investigational or marketed products during pregnancy and/or lactation.
2. Pregnant women / mothers known to suffer from hepatitis B or human immunodeficiency virus (HIV)
3. Pregnant women / mothers known to have other significant medical condition (including during pregnancy) that might interfere with the study or known to affect intra-uterine growth (including, but not limited to: placenta previa, pre-eclampsia, eclampsia, gestational diabetes requiring insulin or oral medication), as per investigator's clinical judgement
4. Incapability of the parents to comply with study protocol or Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements

   Exclusion criteria for the subjects:
5. Infants known to have current or previous illnesses/ conditions or intervention which could interfere with the study (growth), as per investigator's clinical judgement
6. Infants with known congenital diseases or malformations which could interfere with the study (e.g. gastrointestinal malformations, congenital immunodeficiency), as per investigator's clinical judgement
7. Infants who need to be fed with a special diet other than a standard cow's milk-based infant formula
8. Infants who received any other infant formula, except the infant formula given in between birth and the initial breast-feeding (maximum of 3 consecutive days)
9. Infants with any history of or current participation in any other study involving investigational or marketed products.

Primary outcomes:
measure: Weight gain per day
timeFrame: 17 weeks
measure: Total weight gain
timeFrame: 12 months
measure: Sum of skin fold thicknesses
timeFrame: 24 months
Secondary outcomes:
measure: Recumbent length, head circumference, mid-upper arm circumference, skin folds
timeFrame: 17 weeks
measure: Skin-fold thickness
timeFrame: 12 months
measure: Weight, length, BMI, head circumference, mid-upper arm circumference, subscapular skinfold, triceps skinfold
timeFrame: 24 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital, Singapore
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Oon Hoe Teoh, Dr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National University Hospital, Singapore
name: Yap Seng Chong, A/Prof, MD
role: PRINCIPAL_INVESTIGATOR
References: