Nctid:
NCT06234501
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001321", "term"=>"Autistic Disorder"}], "ancestors"=>[{"id"=>"D000067877", "term"=>"Autism Spectrum Disorder"}, {"id"=>"D000002659", "term"=>"Child Development Disorders, Pervasive"}, {"id"=>"D000065886", "term"=>"Neurodevelopmental Disorders"}, {"id"=>"D000001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M4623", "name"=>"Autistic Disorder", "asFound"=>"Autism", "relevance"=>"HIGH"}, {"id"=>"M206", "name"=>"Autism Spectrum Disorder", "relevance"=>"LOW"}, {"id"=>"M5903", "name"=>"Child Development Disorders, Pervasive", "relevance"=>"LOW"}, {"id"=>"M5902", "name"=>"Developmental Disabilities", "relevance"=>"LOW"}, {"id"=>"M30644", "name"=>"Neurodevelopmental Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000025101", "term"=>"Vitamin B 6"}, {"id"=>"D000011730", "term"=>"Pyridoxal"}, {"id"=>"D000011732", "term"=>"Pyridoxal Phosphate"}], "ancestors"=>[{"id"=>"D000014815", "term"=>"Vitamins"}, {"id"=>"D000018977", "term"=>"Micronutrients"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D000014803", "term"=>"Vitamin B Complex"}], "browseLeaves"=>[{"id"=>"M23026", "name"=>"Vitamin B 6", "asFound"=>"Primary care provider", "relevance"=>"HIGH"}, {"id"=>"M14583", "name"=>"Pyridoxal", "asFound"=>"Berg Balance Scale", "relevance"=>"HIGH"}, {"id"=>"M14589", "name"=>"Pyridoxine", "relevance"=>"LOW"}, {"id"=>"M17558", "name"=>"Vitamins", "relevance"=>"LOW"}, {"id"=>"M17546", "name"=>"Vitamin B Complex", "relevance"=>"LOW"}, {"id"=>"M14585", "name"=>"Pyridoxal Phosphate", "asFound"=>"Ospemifene", "relevance"=>"HIGH"}, {"id"=>"M21009", "name"=>"Micronutrients", "relevance"=>"LOW"}, {"id"=>"M16885", "name"=>"Trace Elements", "relevance"=>"LOW"}, {"id"=>"M8618", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"T474", "name"=>"Vitamin B6", "asFound"=>"Primary care provider", "relevance"=>"HIGH"}, {"id"=>"T459", "name"=>"Pyridoxal", "asFound"=>"Berg Balance Scale", "relevance"=>"HIGH"}, {"id"=>"T461", "name"=>"Pyridoxine", "relevance"=>"LOW"}, {"id"=>"T446", "name"=>"Folic Acid", "relevance"=>"LOW"}, {"id"=>"T448", "name"=>"Folate", "relevance"=>"LOW"}, {"id"=>"T475", "name"=>"Vitamin B9", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE", "whoMasked"=>["PARTICIPANT", "INVESTIGATOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>40}}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-30", "studyFirstSubmitDate"=>"2024-01-22", "studyFirstSubmitQcDate"=>"2024-01-30", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-10", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Sensory hyperreactivity", "timeFrame"=>"Baseline and One month", "description"=>"Sensory hyperreactivity will be measured by a subscale of the Sensory Processing Inventory (SP3D."}, {"measure"=>"Sensory hyperreactivity", "timeFrame"=>"Baseline and One month", "description"=>"Sensory hyperreactivity will be measured by a subscale of the Comprehensive Autistic Trait Inventory (CATI)."}, {"measure"=>"Anxiety", "timeFrame"=>"Baseline and One month", "description"=>"Anxiety will be measured using the Screen for Adult Anxiety Related Disorders (SCAARED) questionnaire."}, {"measure"=>"Vitamin B6 status", "timeFrame"=>"Baseline and One month", "description"=>"The concentration of different forms of Vitamin B6 in blood plasma will be measured (Pyridoxal-5'-phosphate, pyridoxine, pyridoxal, pyridoxamine)"}], "secondaryOutcomes"=>[{"measure"=>"ADHD traits", "timeFrame"=>"Baseline and One month", "description"=>"Adult Attention Deficit Hyperreactivity Disorder Self-Report Scale (ASRS-v1.1)"}, {"measure"=>"Sensory processing differences", "timeFrame"=>"Baseline and One month", "description"=>"These will be measured using the other subscales of the Sensory Processing Inventory (SP3D) that do not constitute the primary sensory hyperreactivity outcome described above."}, {"measure"=>"Sleep quality", "timeFrame"=>"Baseline and One month", "description"=>"Pittsburgh Sleep Quality Index (PSQI)"}, {"measure"=>"Visual Surround Suppression of contrast perception", "timeFrame"=>"Baseline and One month", "description"=>"Psychophysical measurements of the contrast threshold will be made, which correspond to the minimum physical stimulus contrast that can be reliably detected by an observer. The test measures the increase in the threshold caused by introducing spatial inhibition of the target stimuli, which is a parameter that has been shown to correlate with GABA concentration in the brain (Yoon et al., 2010)."}, {"measure"=>"Surround Suppression of Motion duration detection thresholds", "timeFrame"=>"Baseline and One month", "description"=>"Psychophysical measurements of the motion duration threshold will be made, which correspond to the number of milliseconds an observer requires to detect whether a Gabor patch is drifting left or right. The test measures the increase in the threshold caused by spatial inhibition, which is a parameter that has been shown to differ in various patient groups, including autism (Foss-Feig et al. 2013)."}, {"measure"=>"Binocular Rivalry reversal rate", "timeFrame"=>"Baseline and One month", "description"=>"A test based on presenting ambiguous visual stimuli that cause perceptual reversals; how frequently the perceptual reversals occur is measured and has been shown to be related to GABA levels (Mentch et al., 2019)."}, {"measure"=>"Binocular Rivalry suppression index", "timeFrame"=>"Baseline and One month", "description"=>"A test based on presenting ambiguous visual stimuli that cause perceptual reversals; the proportion of time for which the stimulus appears unclear rather than stable is measured and has been shown to be related to GABA levels (Mentch et al., 2019)."}, {"measure"=>"Measurement of Weber Fraction for size perception", "timeFrame"=>"Baseline and One month", "description"=>"The Weber fraction is the percentage change in a physical quantity required for an observer to reliably detect that a change has occurred, and for a specific stimulus type it is generally a fixed percentage regardless of the magnitude of the stimuli. We will measure the Weber Fraction for visual size perception at four separate starting sizes, and the outcome measure derived from doing that will be a measurement of the stability/instability of the Weber Fraction across the four starting sizes. It has been reported that in autism the general finding of fixed Weber fractions across a range of physical stimuli does not hold (Hadad \\& Schwartz, 2019): we are taking the opportunity to replicate this finding."}, {"measure"=>"Tilt illusion magnitude", "timeFrame"=>"Baseline and One month", "description"=>"Magnitude of the tilt illusion is a correlate of GABA concentration in the occipital cortex (Song et al., 2017)."}, {"measure"=>"Ebbinghaus illusion magnitude", "timeFrame"=>"Baseline and One month", "description"=>"Magnitude of the Ebbinghaus illusion is a correlate of gamma y-Aminobutyric acid (GABA) concentration in the parietal lobe (Song et al. 2017)"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Vitamin B6", "Sensory Hyperreactivity", "GABA", "Excitation-Inhibition Balance"], "conditions"=>["Autism"]}, "referencesModule"=>{"references"=>[{"pmid"=>"20220012", "type"=>"BACKGROUND", "citation"=>"Yoon JH, Maddock RJ, Rokem A, Silver MA, Minzenberg MJ, Ragland JD, Carter CS. GABA concentration is reduced in visual cortex in schizophrenia and correlates with orientation-specific surround suppression. J Neurosci. 2010 Mar 10;30(10):3777-81. doi: 10.1523/JNEUROSCI.6158-09.2010."}, {"pmid"=>"31451579", "type"=>"BACKGROUND", "citation"=>"Mentch J, Spiegel A, Ricciardi C, Robertson CE. GABAergic Inhibition Gates Perceptual Awareness During Binocular Rivalry. J Neurosci. 2019 Oct 16;39(42):8398-8407. doi: 10.1523/JNEUROSCI.0836-19.2019. Epub 2019 Aug 26."}, {"pmid"=>"28821653", "type"=>"BACKGROUND", "citation"=>"Song C, Sandberg K, Andersen LM, Blicher JU, Rees G. Human Occipital and Parietal GABA Selectively Influence Visual Perception of Orientation and Size. J Neurosci. 2017 Sep 13;37(37):8929-8937. doi: 10.1523/JNEUROSCI.3945-16.2017. Epub 2017 Aug 14."}, {"pmid"=>"30829198", "type"=>"BACKGROUND", "citation"=>"Hadad BS, Schwartz S. Perception in autism does not adhere to Weber's law. Elife. 2019 Mar 4;8:e42223. doi: 10.7554/eLife.42223."}, {"pmid"=>"23658163", "type"=>"BACKGROUND", "citation"=>"Foss-Feig JH, Tadin D, Schauder KB, Cascio CJ. A substantial and unexpected enhancement of motion perception in autism. J Neurosci. 2013 May 8;33(19):8243-9. doi: 10.1523/JNEUROSCI.1608-12.2013. Erratum In: J Neurosci. 2013 Jun 19;33(25):10583."}]}, "descriptionModule"=>{"briefSummary"=>"This clinical trial aims to explore the effect of Vitamin B6 supplementation on anxiety sensory hyperreactivity in autistic adults. Researchers will compare a placebo group to high-dose Vitamin-B6 to see if vitamin B6 reduce anxiety and sensory reactivity differences in autism.", "detailedDescription"=>"The main question it aims to answer is:\n\n* Does high-dose Vitamin B6 supplementation reduce sensory hyperreactivity differences in autism?\n* Does high-dose Vitamin B6 supplementation reduce anxiety differences in autism?\n* Explore the effects of vitamin B6 on sleep quality, Attention Deficit Hyperactivity Disorder (ADHD) scores, and various visual perception tasks that are indicative of GABAergic activity"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT"], "maximumAge"=>"60 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Between the ages of 18 to 60\n* With a diagnosis of autism\n\nExclusion Criteria:\n\n* Taking any supplement that contains more than 2mg of Vitamin B6 or taking GABA agonist drugs\n* Have a medical history of peripheral neuropathy\n* lactose intolerance (placebo tablet is lactose based)"}, "identificationModule"=>{"nctId"=>"NCT06234501", "briefTitle"=>"Testing the Efficacy of 100mg Vitamin-B6 Daily for Sensory Reactivity in Autism", "organization"=>{"class"=>"OTHER", "fullName"=>"University of Reading"}, "officialTitle"=>"Testing the Potential of High-dose Vitamin B6 Supplements for Sensory Reactivity in Autism", "orgStudyIdInfo"=>{"id"=>"UREC23/27"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Vitamin-B6", "description"=>"Participants will consume one high-dose Vitamin B6 100 mg tablet orally once daily for one month. Vitamin B6 will be provided as Pyridoxal-5'-Phosphate (PLP)", "interventionNames"=>["Dietary Supplement: Pyridoxal 5'-Phosphate (100 mg)"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Placebo", "description"=>"Participants will consume a Placebo tablet matching the appearance of the Vitamin B6 tablets in the Experimental arm orally once daily for one month.", "interventionNames"=>["Other: Placebo"]}], "interventions"=>[{"name"=>"Pyridoxal 5'-Phosphate (100 mg)", "type"=>"DIETARY_SUPPLEMENT", "otherNames"=>["Vitamin B6"], "description"=>"100 mg Pyridoxal 5'-Phosphate tablet once daily with food", "armGroupLabels"=>["Vitamin-B6"]}, {"name"=>"Placebo", "type"=>"OTHER", "otherNames"=>["Control group"], "description"=>"Placebo tablet once daily", "armGroupLabels"=>["Placebo"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"RG6 6AL", "city"=>"Reading", "country"=>"United Kingdom", "contacts"=>[{"name"=>"David Field", "role"=>"CONTACT", "email"=>"d.t.field@reading.ac.uk", "phone"=>"0118 378 8523"}], "facility"=>"University of Reading", "geoPoint"=>{"lat"=>51.45625, "lon"=>-0.97113}}], "centralContacts"=>[{"name"=>"Dr David T Field, PhD", "role"=>"CONTACT", "email"=>"d.t.field@reading.ac.uk", "phone"=>"+441183785004"}, {"name"=>"Alex Cameron, MSc", "role"=>"CONTACT", "email"=>"a.cameron@pgr.reading.ac.uk"}], "overallOfficials"=>[{"name"=>"Dr David T Field, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"University of Reading"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"University of Reading", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"INNOPURE", "class"=>"UNKNOWN"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Associate professor", "investigatorFullName"=>"David Field", "investigatorAffiliation"=>"University of Reading"}}}}
