New Infant Formula Trial in Healthy Term Subjects on Growth, Body Composition, Tolerance and Safety (Venus)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Danone Asia Pacific Holdings Pte, Ltd.
Sponsor:
Collaborator:
Nutricia Research
Information provided by (Responsible Party):
Danone Asia Pacific Holdings Pte, Ltd.
ClinicalTrials.gov Identifier:
NCT01609634
First received: May 29, 2012
Last updated: July 16, 2014
Last verified: July 2014

May 29, 2012
July 16, 2014
July 2012
July 2014   (final data collection date for primary outcome measure)
  • Weight gain per day [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
    Weight gain per day from randomisation until 17 weeks of age.
  • Total weight gain [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Total weight gain from birth until 12 months of age
  • Sum of skin fold thicknesses [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Sum of skin fold thicknesses: triceps, biceps, suprailiac, subscapular until 24 months of age in subjects receiving the test product 1, test product 2, or control product.
Same as current
Complete list of historical versions of study NCT01609634 on ClinicalTrials.gov Archive Site
  • Recumbent length, head circumference, mid-upper arm circumference, skin folds [ Time Frame: 17 weeks ] [ Designated as safety issue: No ]
    Recumbent length, head circumference, mid-upper arm circumference, skin folds gain per day for subjects receiving test product 1 or test product 2
  • Skin-fold thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Sum of four Skin-fold thickness: triceps, biceps, subscapular and suprailiac measured until 12 months of age
  • Weight, length, BMI, head circumference, mid-upper arm circumference, subscapular skinfold, triceps skinfold [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Weight, length, BMI, head circumference, mid-upper arm circumference, subscapular skinfold, triceps skinfold measured until 24 months of age
Same as current
Not Provided
Not Provided
 
New Infant Formula Trial in Healthy Term Subjects on Growth, Body Composition, Tolerance and Safety
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.

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Healthy Infants
  • Other: Standard infant formula/follow-on formula
    Standard infant formula/follow-on formula with added scGOS/lcFOS
  • Other: Standard infant formula/follow-on formula
    Standard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis®
  • Other: Standard infant formula/follow-on formula
    Control group: Standard infant formula/follow-on formula with standard fat droplets and without specific prebiotic oligosaccharides.
  • Active Comparator: Intervention group 1
    Intervention group 1: Standard infant formula/follow-on formula with added scGOS/lcFOS
    Intervention: Other: Standard infant formula/follow-on formula
  • Active Comparator: Intervention group 2
    Intervention group 2: Standard infant formula/follow-on formula with added scGOS/lcFOS and Nuturis®
    Intervention: Other: Standard infant formula/follow-on formula
  • Placebo Comparator: Control group
    Control group: Standard infant formula/follow-on formula with added standard fat droplets and without specific prebiotic oligosaccharides.
    Intervention: Other: Standard infant formula/follow-on formula
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
530
July 2016
July 2014   (final data collection date for primary outcome measure)

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.
Both
up to 28 Days
Yes
Contact: Jill Wong, MSc jill.wong@danone.com
Contact: Antoinette Winokan, MD antoinette.winokan@danone.com
Singapore
 
NCT01609634
EPI.2.C/A
Yes
Danone Asia Pacific Holdings Pte, Ltd.
Danone Asia Pacific Holdings Pte, Ltd.
Nutricia Research
Principal Investigator: Yung Chiang Kenneth Kwek, A/Prof, MD KK Women's and Children's Hospital
Principal Investigator: Yap Seng Chong, A/Prof, MD National University Hospital, Singapore
Danone Asia Pacific Holdings Pte, Ltd.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP