NCT00342303

Brief Summary

We will test the following hypotheses:

  1. 1.The activity of the desaturating/elongating enzymes assessed by the in vivo conversion of deuterated a-linolenic and linoleic acids to DHA and AA, respectively, will be related to the duration of gestation and to postnatal age.
  2. 2.Dietary w-3 and w-6 LCPUFAs in human milk or DHA and AA supplemented formula will inhibit the desaturation/elongation of deuterated a-linolenic and linoleic acids demonstrating in vivo inhibition of the metabolic pathway by respective products.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 1993

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 1993

Completed
13 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2010

Completed
Last Updated

July 2, 2017

Status Verified

July 13, 2010

First QC Date

June 19, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

Premature InfantsFatty Acid MetabolismPolyunsaturated Fatty AcidsInfant FormulaGas-chromatographyMass Spectrometry

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Newborns with birth weights appropriate for their gestational age born at 28, 32, 36 and 40 weeks gestation that are recovering from common neonatal morbidity will be recruited to enter the study before 5 days of age. This disease condition will not be life threatening at the time of study.
  • The typical disease conditions expected based on the pilot phase of study are infants recovering from asphyxia, infants recovering from transient tachypnea, infants recovering from suspect pneumonia, infants recovering from hyaline membrane disease.
  • Newborns with birth weights below the tenth percentile of the weight distribution for a given gestational age born at 30-34 and 36-38 weeks gestation.
  • Will include infants born at 28 to 40 weeks who are free of major neonatal morbidity and will be recruited to enter the study at 10 days of age.

You may not qualify if:

  • Maternal factors which may affect their fatty acid metabolism of the neonate.
  • Vegetarian or vegan diet during pregnancy
  • Metabolic disease which may affect essential fatty acid status of the fetus (hyperlipidemia, diabetes)
  • Postnatal factors:
  • Birth weight inadequate for gestational age (birth weight below the 10th percentile or above the 90th percentile for gestational age)
  • Significant acute neonatal morbidity which interferes with normal lipid metabolism during the study period. Infants who are recovering from common neonatal morbidities that do not have obvious effects on elongase/desaturase activity will not be excluded.
  • Feeding other than prescribed for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinica Presbiteriana Madre Hijo

Santiago, Chile

Location

Hospital Luis Tisne

Santiago, Chile

Location

Related Publications (3)

  • Lee AG, East JM, Froud RJ. Are essential fatty acids essential for membrane function? Prog Lipid Res. 1986;25(1-4):41-6. doi: 10.1016/0163-7827(86)90009-3. No abstract available.

    PMID: 2962202BACKGROUND
  • Glomset JA. Fish, fatty acids, and human health. N Engl J Med. 1985 May 9;312(19):1253-4. doi: 10.1056/NEJM198505093121909. No abstract available.

    PMID: 3990716BACKGROUND
  • Sprecher H. Biochemistry of essential fatty acids. Prog Lipid Res. 1981;20:13-22. doi: 10.1016/0163-7827(81)90009-6. No abstract available.

    PMID: 7342077BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

June 8, 1993

Study Completion

July 13, 2010

Last Updated

July 2, 2017

Record last verified: 2010-07-13

Locations