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"#  '(*)"$`~b^=Zc#R$pxJ# mG$"$>~ $mMrL$"$^h+rFjlU$$$$"$RHw׌͗] 0AA0 3f@8FGg4HdHd 08ppp@  <4BdBd8c20loO ʚ;[)e8ʚ;<4dddd8108<4!d!d810880___PPT10 pp?  %6sJA randomised control trial of diet in adults with previously untreated PKUKK(}Lesley Robertson Research Dietitian The National Hospital for Neurology and Neurosurgery University College London Hospitals .~P$Yu&PKU Learning Disability Research Group''(Formed 1999 Designed the protocol and secured funding for the study Members of the Steering Group : Dr Philip Lee Professor Glynis Murphy Dr Brian Fitzgerald Eleanor Weetch Rosemary Hoskin Maggie Lilburn Pat Portnoi Carole Coleman &dZZOutline of presentation Katie s story Finding participants Background and summary to the project Outcome of the 36 participants Blood results Behaviour results Summary Story of Janet, a lady who participated in the trial ZTJWhat we have discovered ?Statistics led us to believe there could be 1500  1800 people living in the UK with untreated PKU To date, we have found 157 adults  living predominately in care homes for people with learning disability We recruited 36 people onto the trialp#Barriers to locating and recruiting$$jPeople s medical notes don t follow them around  staff unaware of diagnosis Staff  social care and local medical teams suspicious of research Either to give initial info when locating Consent to be part of trial Care staff unable to accept PKU diet, feel cruel,  I couldn t cut out meat, why should they HZGZ_ZG_aT(Charactersitics of 157 adults identified))bU2Social care needs of adults suitable for the trial33cVMedical SymptomsiWellcome Trust GrantrFunded 3 year study  to assess the effect of low phenylalanine diet in 36 previously untreated adults Two full time researchers :- psychologist and dietitian Researchers started on the project in Summer 2003 Support from NSPKU SHS Steering Group ZZ(Z@ZMZ@M XPNational studyC$ qInclusion CriteriaAdults with PKU but never treated by diet Severe learning disability Presence of challenging behaviour Plasma phenylalanine > 1200 mol/L Consent from carer and or family LkZZFZC# #gResearch ProtocolA double-blind placebo crossover trial to assess the efficacy of phenylalanine restriction in 36 adults previously untreated PKU Length of trial - 60 weeks split into 4 sections  including a trial of a PKU and a non-PKU diet Behaviour monitored throughout each phase 2.Research Protocol DiagramA hDietary ManagementXNormal care home diet eaten during the baseline and washout Food in diet 1 and 2 was low phenylalanine Amino acid supplement - the difference in two phases On active diet (PKU diet) XP Maxamum given On placebo diet (non PKU diet) the amino acid supplement contained phenylalanine  P Maxamum -0Z--E<@Monitoring  blood and behaviour!!tBlood tests  weekly finger pricks Behaviour monitoring Daily behaviour diary 2 standardised questionnaires at each of five visits 3 short video s of each participant at the five visits *88mY&The 36 Adults enrolled onto the trial '% 17 completed full 60 weeks 9 remain on PKU diet 8 on returned to normal diet 3 withdrew on diet 2(following deterioration of behaviour) to follow PKU diet 7 withdrew during baseline 4 unable to do bloods 3 disliked amino acid supplement 5 withdrew during diet 1  all unable to take amino acid supplement 3 withdrew at carers request on diet 2 1 withdrawn as failed to meet study criteria P2PiP7PP2;7}Blood Phenylalanine}eBehaviour MonitoringWDaily behaviour diary 3 positive behaviours 3 negative behaviours Carers comments Standardised questionnaires Vineland Adaptive Behaviour Scales (VABS) Aberrant Behaviour Checklist (ABC) Video of 3 situations At mealtime, doing puzzles, on own Measured time spent (in seconds) on challenging behaviour, concentration on task, and communicationZ<ZZMZZZ<M  o[Daily Behaviour DiariesE 3 positive behaviours - standardised for everyone Concentration Social responsiveness Communication 3 Negative behaviours- individualised Screaming, shouting Aggression - grabbing, hitting, punching Invading space Self harm Smearing and/or stripping Agitation Hitting/banging doors or throwing things Carers comments4P3PP&PPP43&  ~@Behaviour Analysis  daily diary!!FDaily behaviour diary No correlation between Phe level and negative behaviours No correlation between Phe level and positive behaviours No correlation between negative behaviours and positive behaviours Very positive carer comments - 250 were analysed and statistically significant  0.001 ZZZWZZ*A|W  ,.6~fCarers commentsZWe have some clear descriptions of clients changed behaviour Intensity of negative behaviour decreases Length of negative behaviour deceases Receptive to others and aware of others feelings  allowing staff to work on improving negative behaviour Communication becomes clearer and more concise The participants often been undertaking behaviour for many years  time is needed to see marked benefit and undo learned behaviour H?ZZZ?k Carer commentl Carer commentm Carer commentn Carer commentjStandardised QuestionnairespNo significant difference between active and placebo on either Vineland Adaptive Behaviour Scales (VABS) Aberrant Behaviour Checklist (ABC) Need a more sensitive tool Katie s story V@M*@M*|dVideo data collected at visitsNo differences between phases  i.e. between Normal diet, Active diet or Placebo diet: Observed instances of challenging behaviour Time concentrating during meal or on task Observed gestures, repetitive speech and conversation Interest and success doing puzzles BYZZZY]SSummarysDifficult to find adults with previously untreated PKU 36 people recruited to the trial Blood results of 17 completers BL 1582 mol/L PKU diet 572 mol/L WO 1520 mol/L Non PKU diet 1474mol/L Carers comments most powerful evidence when analysing behaviour From the 17 completers and the 3 who withdrew early to follow PKU diet, 60% are still on diet fwP]PPPw]WM Thank You  To Jan and Carolyne Care Homes Steering Group NSPKU SHS My colleagues at Charles Dent Metabolic Unit, The National Hospital for Neurology and Neurosurgery, University College London HospitalsP /sn 0` 33PP` 13` 3333` Q_{` 333fpKNāvI` j@v۩ῑ΂H>?" dd@,?n<d@ `7 `2@`7``2 n?" dd@   @@``PR    @ ` ` p>>    & (    <& F 0   Ng"P F 0   <F"p F 0   C xDY?d?"bUv F 0    < #" `   T Click to edit Master title style! !$   0 "   RClick to edit Master text styles Second level Third level Fourth level Fifth level!     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