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Effects of Different ARA Formulations of Infant Formula on Fatty Acid Status, Immune Markers and Infection Rates in Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03014115
Recruitment Status : Completed
First Posted : January 9, 2017
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
SynteractHCR
Information provided by (Responsible Party):
DSM Nutritional Products, Inc.

Tracking Information
First Submitted Date  ICMJE January 3, 2017
First Posted Date  ICMJE January 9, 2017
Last Update Posted Date January 18, 2020
Study Start Date  ICMJE November 2016
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
total plasma fatty acid ARA levels [ Time Frame: 6 months of supplementation ]
difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
  • incidence of infections [ Time Frame: 6 months of supplementation ]
    record number, type and duration of infections
  • weight gain [ Time Frame: 6 months of supplementation ]
    differences between groups in weight gain (kg/d)
  • length gain [ Time Frame: 6 months of supplementation ]
    differences between groups in length gain (cm/d)
  • head circumference [ Time Frame: 6 months of supplementation ]
    differences between groups in head circumference (cm/d)
  • dietary intake of ARA [ Time Frame: 6 months of supplementation ]
    24 hour recall questionnaire
  • plasma levels of immune markers [ Time Frame: 6 months of supplementation ]
    cytokines and T cells levels in plasma will be measured
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Different ARA Formulations of Infant Formula on Fatty Acid Status, Immune Markers and Infection Rates in Infants
Official Title  ICMJE EFFECTS OF DIFFERENT ARA FORMULATIONS OF INFANT FORMULA ON FATTY ACID STATUS, IMMUNE MARKERS AND INFECTION RATES IN INFANTS
Brief Summary The clinical trial will investigate the effect of different formulations of ARA + 0.4% DHA in infant formula on plasma fatty acid status in healthy 6 months old infants supplemented for 6 months. A 6-month follow on phase will provide additional efficacy (e.g. infection rates, immune markers) and safety information in these 12-18 month old infants.
Detailed Description This study is a randomized, double-blind, parallel-group study of 0% ARA +0.4% DHA or 0.76% ARA +0.4% DHA supplemented infant formula provided to 6 months old healthy infants for 6 months. Infants will have been breast-fed or formula-fed prior to enrollment. The difference in total plasma fatty acid ARA levels between the two groups at 6 months of supplementation will be measured. Parents will be asked about the infant's current daily diet (fatty acid intakes calculated via 24 hour recalls). All completed infants will be enrolled into a 6 month extension period (non-supplemented) to collect additional measures of efficacy (i.e. infections and illnesses, immune markers) and safety out to 18 months of age.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy Infants
Intervention  ICMJE
  • Dietary Supplement: combination ARA + DHA
    combination ARA + DHA supplemented infant formula
    Other Name: infant formula
  • Dietary Supplement: DHA
    DHA supplemented infant formula
    Other Name: infant formula
Study Arms  ICMJE
  • Active Comparator: combination ARA+ DHA
    combination 0.76% ARA+ 0.4% DHA in infant formula per day
    Intervention: Dietary Supplement: combination ARA + DHA
  • Experimental: DHA
    0% ARA +0.4% DHA in infant formula per day
    Intervention: Dietary Supplement: DHA
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2018)
110
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2017)
220
Actual Study Completion Date  ICMJE August 2019
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • singleton infants,
  • parent of legal age to consent,
  • willing to feed the child the assigned study formula for the treatment duration,
  • parent agrees to scheduled blood draws

Exclusion Criteria:

  • exclusively breastfed or formula-fed beyond 6 months,
  • difficulty swallowing or other congenital malformation or metabolic anomaly,
  • taking omega-3 (supplemented) foods,
  • mother had gestational diabetes or is Type II diabetic,
  • born at <37 weeks gestational age,
  • participating in another study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Weeks to 26 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03014115
Other Study ID Numbers  ICMJE 2015-1080
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party DSM Nutritional Products, Inc.
Study Sponsor  ICMJE DSM Nutritional Products, Inc.
Collaborators  ICMJE SynteractHCR
Investigators  ICMJE
Principal Investigator: Ascension Marcos, PhD Instituto de Ciencia y Tecnología de Alimentos y Nutrición
PRS Account DSM Nutritional Products, Inc.
Verification Date January 2020

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