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NCT02907502Completed

Toddler Milk Intervention Trial

Effects of Milk Protein Intake in Young Children on Early Growth and Later Obesity Risk: a Multicentre Randomized Clinical Trial

Source: ClinicalTrials.gov · Last updated 6 Dec 2024

Brief summary (registry, in English)

To assess growth of children (enrolled between 11.5 and 13.5 months) fed with two iso-energetic, young-child formulas with different protein content during the second year of life

Status (registry)
Completed
Study type
Interventional
Enrollment
1618 (actual)
First submitted
31 Aug 2016
Start date
Sept 2016
Primary completion date
Jul 2021
Lead sponsor
Société des Produits Nestlé (SPN)
Diseases
Obesity
NCT number
NCT02907502

What you commit to

  • Study type: Interventional
  • Participants enrolled: 1618
  • From Sept 2016 to the primary completion date, Jul 2021
  • 2 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participation in any other interventional clinical trial during the 4 weeks prior to enrollment

Other illness

  • Diagnosed disorder considered to interfere with nutrition or growth (e.g. malabsorptive disorders as short bowel syndrome, inflammatory bowel disease; neurological and congenital disorders that may delay growth as cerebral palsy, agenesis of the corpus callosum, spina bifida, Down Syndrome, Cri Du Chat; disorders that may lead to obesity: Prader willi syndrome, Angelman syndrome, etc.)
  • Cows' milk allergy

Other

  • Lactose intolerance
  • Infant who is being breastfed at the time of enrollment
  • Infant who does not usually drink 300ml of cow's and/or formula milk per day
  • Institutionalized children
  • Child or child's family who in the Investigator's judgment cannot be expected to comply with the protocol or study procedures

Who the study is looking for

  • Having obtained his/her parents' (or his/her legally accepted representative \[LAR's\] written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parents/LAR have been informed of all pertinent aspects of the study
  • Child was born full term (≥ 37 weeks of gestation)
  • Age at enrollment: between 11.5 months and 13.5 months of age
  • 2.5 kg ≤ birth weight ≤ 4.5 kg
  • Born from a singleton pregnancy
  • Child's parent(s)/LAR is of legal age of consent, has sufficient local language skills to complete the informed consent and other study documents, is able to be contacted directly by telephone throughout the study, and is willing and able to fulfill the requirements of the study protocol.

Age in the registry: 11 months to 13 months · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dr Von Hauner Children's hospital
Coordinator of this site? Confirm its status
MunichGermanyUnknown status
Hospital Universitari Joan 23 de Tarragona. Universitat Rovira i Virgili.
Coordinator of this site? Confirm its status
TarragonaSpainUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.