Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
43 participants
OBSERVATIONAL
2006-08-31
2010-12-31
Brief Summary
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Detailed Description
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Two specific aims will test the following hypotheses:
1. Shortening of MR T1 and T2 relaxation times (a marker for Mn) in Mn-sensitive brain regions in neonates receiving PN will correlate directly with
* dietary Mn intake,
* days on PN,
* blood Mn levels (measured by Inductively Coupled Plasma-Mass Spectrometry)
* hepatic dysfunction/cholestasis (assessed by conjugated bilirubin levels).
2. shortening of T1 and T2 relaxation times will correlate inversely with
* gestational age
* Fe status (assessed by serum Fe, ferritin, transferrin, soluble transferrin receptor and hemoglobin).
The potential for increased brain Mn accumulation in infants and the potential health risks associated with elevated brain Mn burden represent crucial, unexplored issues of exposure and susceptibility. The impact of dietary Mn, and especially parenterally delivered dietary Mn, gestational age, Fe status, and hepatic dysfunction on the ability of the neonatal brain to regulate Mn deposition has not been scientifically addressed. The proposed clinical investigation has enormous health significance and may shed light on the development and progression of neurological dysfunction in infants and children on prolonged parenteral nutrition.
Conditions
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Keywords
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Study Design
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PROSPECTIVE
Interventions
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remove Mn from PN if evidence of increased brain Mn on MRI
trace element cocktail will be withheld and zinc, copper and chromium added to PN individually.
Eligibility Criteria
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Inclusion Criteria
2. In the preceding four weeks have received \>75% of their nutrition as Mn-supplemented PN
3. Clinically stable for transport to the MR facility
4. Signed parental consent.
Exclusion Criteria
2. Not expected to achieve sufficient clinical stability to tolerate the MRI procedure.
30 Days
12 Months
ALL
No
Sponsors
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National Institute of Environmental Health Sciences (NIEHS)
NIH
Vanderbilt University
OTHER
Responsible Party
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Judy Aschner
Adjunct Professor of Pediatrics
Principal Investigators
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Judy L Aschner, MD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt Children's Hospital
Nashville, Tennessee, United States
Countries
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References
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Aschner JL, Aschner M. Nutritional aspects of manganese homeostasis. Mol Aspects Med. 2005 Aug-Oct;26(4-5):353-62. doi: 10.1016/j.mam.2005.07.003.
Erikson KM, Thompson K, Aschner J, Aschner M. Manganese neurotoxicity: a focus on the neonate. Pharmacol Ther. 2007 Feb;113(2):369-77. doi: 10.1016/j.pharmthera.2006.09.002. Epub 2006 Sep 22.
Fitsanakis VA, Zhang N, Avison MJ, Gore JC, Aschner JL, Aschner M. The use of magnetic resonance imaging (MRI) in the study of manganese neurotoxicity. Neurotoxicology. 2006 Sep;27(5):798-806. doi: 10.1016/j.neuro.2006.03.001. Epub 2006 Apr 18.
Fitsanakis VA, Piccola G, Marreilha dos Santos AP, Aschner JL, Aschner M. Putative proteins involved in manganese transport across the blood-brain barrier. Hum Exp Toxicol. 2007 Apr;26(4):295-302. doi: 10.1177/0960327107070496.
Yin Z, Aschner JL, dos Santos AP, Aschner M. Mitochondrial-dependent manganese neurotoxicity in rat primary astrocyte cultures. Brain Res. 2008 Apr 8;1203:1-11. doi: 10.1016/j.brainres.2008.01.079. Epub 2008 Feb 11.
Aschner JL, Anderson A, Slaughter JC, Aschner M, Steele S, Beller A, Mouvery A, Furlong HM, Maitre NL. Neuroimaging identifies increased manganese deposition in infants receiving parenteral nutrition. Am J Clin Nutr. 2015 Dec;102(6):1482-9. doi: 10.3945/ajcn.115.116285. Epub 2015 Nov 11.
Other Identifiers
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ES013730
Identifier Type: -
Identifier Source: secondary_id
ES013730
Identifier Type: -
Identifier Source: org_study_id