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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.

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.

Condition or disease Intervention/treatment Phase
Healthy Infants Dietary Supplement: combination ARA + DHA Dietary Supplement: DHA Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: EFFECTS OF DIFFERENT ARA FORMULATIONS OF INFANT FORMULA ON FATTY ACID STATUS, IMMUNE MARKERS AND INFECTION RATES IN INFANTS
Study Start Date : November 2016
Actual Primary Completion Date : May 2019
Actual Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: combination ARA+ DHA
combination 0.76% ARA+ 0.4% DHA in infant formula per day
Dietary Supplement: combination ARA + DHA
combination ARA + DHA supplemented infant formula
Other Name: infant formula

Experimental: DHA
0% ARA +0.4% DHA in infant formula per day
Dietary Supplement: DHA
DHA supplemented infant formula
Other Name: infant formula




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. incidence of infections [ Time Frame: 6 months of supplementation ]
    record number, type and duration of infections

  2. weight gain [ Time Frame: 6 months of supplementation ]
    differences between groups in weight gain (kg/d)

  3. length gain [ Time Frame: 6 months of supplementation ]
    differences between groups in length gain (cm/d)

  4. head circumference [ Time Frame: 6 months of supplementation ]
    differences between groups in head circumference (cm/d)

  5. dietary intake of ARA [ Time Frame: 6 months of supplementation ]
    24 hour recall questionnaire

  6. plasma levels of immune markers [ Time Frame: 6 months of supplementation ]
    cytokines and T cells levels in plasma will be measured



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Weeks to 26 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014115


Locations
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Spain
Centro de Salud Aravaca
Madrid, Spain
Centro Salud Arganda del Rey
Madrid, Spain
Sponsors and Collaborators
DSM Nutritional Products, Inc.
SynteractHCR
Investigators
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Principal Investigator: Ascension Marcos, PhD Instituto de Ciencia y Tecnología de Alimentos y Nutrición
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Responsible Party: DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier: NCT03014115    
Other Study ID Numbers: 2015-1080
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by DSM Nutritional Products, Inc.:
arachidonic
docosahexaenoic acid
infant formula
Additional relevant MeSH terms:
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Infection