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Fetal Alcohol Spectrum Disorder-Is This a Ciliopathy?

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: NCT03802708
Recruitment Status : Completed
First Posted : January 14, 2019
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Helly Goez, University of Alberta

Brief Summary:

Urine sample and exhaled Nitric Oxide will analyzed and compared between children diagnosed with Fetal Alcohol Spectrum Disorder and healthy control.

Pilot study- 5 children in each group


Condition or disease Intervention/treatment Phase
Fetal Alcohol Spectrum Disorder Diagnostic Test: Metabolomic analysis urine sample Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: pilot. 5 children with FASD- 5 healthy children
Masking: None (Open Label)
Masking Description: this is N/A
Primary Purpose: Basic Science
Official Title: Fetal Alcohol Spectrum Disorder-Is This a Ciliopathy?
Actual Study Start Date : September 1, 2018
Actual Primary Completion Date : January 1, 2020
Actual Study Completion Date : March 23, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
control
control
Diagnostic Test: Metabolomic analysis urine sample
a urine sample will be anlayzed for metabolic pathways involving Nitric Oxide Nitric Oxide level will be measured at the exhaled air sample
Other Name: NO- Analyzer breath test




Primary Outcome Measures :
  1. Nitric Oxide metabolites in urine [ Time Frame: At time of enrollment ]
    metabolomic analysis


Secondary Outcome Measures :
  1. nitric oxide concentration [ Time Frame: At time of enrollment ]
    NO-Analyzer breath test



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children ages 5-16
  • Diagnosis of FASD

Exclusion Criteria:

  • Sinopulmonary anomaly
  • Cardiac anomaly
  • Asthma
  • Previously known Genetic condition
  • Previously known Metabolic condition
  • Polypharmacy

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): NCT03802708


Locations
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Canada, Alberta
Glenrose rehabilitation hospital
Edmonton, Alberta, Canada, T5G 0B7
Sponsors and Collaborators
University of Alberta
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Responsible Party: Helly Goez, Principal Investigator, University of Alberta
ClinicalTrials.gov Identifier: NCT03802708    
Other Study ID Numbers: Pro00076905
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: results from analysis will be available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fetal Alcohol Spectrum Disorders
Ciliopathies
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn