Activity of Essential Fatty Acid Elongation/Desaturation Pathway During Early Life in Human Infants, In Vivo
Essential Fatty Acid Metabolism in the Newborn: Equivalence of Precusors and Mediators in the Synthesis of Long Chain Polyunsaturated Fatty Acids of the n-6 and n-3 Series
2 other identifiers
observational
110
1 country
2
Brief Summary
We will test the following hypotheses:
- 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.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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 1993
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 8, 1993
CompletedFirst Submitted
Initial submission to the registry
June 19, 2006
CompletedFirst Posted
Study publicly available on registry
June 21, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 13, 2010
CompletedJuly 2, 2017
July 13, 2010
June 19, 2006
June 30, 2017
Conditions
Keywords
Eligibility Criteria
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
Hospital Luis Tisne
Santiago, Chile
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: 2962202BACKGROUNDGlomset 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: 3990716BACKGROUNDSprecher 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
Condition Hierarchy (Ancestors)
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