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Trial registered on ANZCTR


Registration number
ACTRN12612000207819
Ethics application status
Approved
Date submitted
13/02/2012
Date registered
20/02/2012
Date last updated
7/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Therapeutic Approaches to Nutrition in Ataxia-Telangiectasia: a Randomised Controlled Matched Cross-over Trial
Scientific title
A randomised controlled age-matched cross-over trial design in individuals diagnosed with Ataxia-telangiectasia to examine the efficacy of standard and therapeutic nutritional interventions to reduce inflammation and neurodegeneration
Secondary ID [1] 279934 0
Nil secondary ID
Universal Trial Number (UTN)
Trial acronym
Nutrition in A-T
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ataxia-telangiectasia 285841 0
Condition category
Condition code
Diet and Nutrition 286021 286021 0 0
Other diet and nutrition disorders
Human Genetics and Inherited Disorders 286022 286022 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be matched for age and randomised to Group A and Group B. All will be required to follow advice from the same dietitian during 2 x 12-week treatment periods: Treatment period 1 - Group A will receive i) standard nutritional advice (to meet individual energy/protein and recommended nutrient requirements including standard vitamin and mineral supplement) and Group B will receive ii) standard nutritional advice (to meet individual energy/protein and recommended nutrient requirements including standard vitamin and mineral supplement) PLUS therapeutic antioxidant-rich food-based advice (individuals provided with food-based ingredients and instructions for making into an anti-oxidant-rich drink). This will be followed by a 4-week washout period. Groups will then cross-over treatments. Treatment period 2 - Group A will receive ii) standard nutritional advice PLUS therapeutic antioxidant-rich food-based advice and Group A will receive i) standard nutritional advice. All participants will receive an initial 1 hour one-on-one session with the dietitian followed by weekly telephone calls from the dietitian allowing a half hour to answer questions and provide support.
Intervention code [1] 284254 0
Lifestyle
Comparator / control treatment
The control treatment is: i) standard nutritional advice (to meet individual energy/protein and recommended nutrient requirements including standard vitamin and mineral supplement). Groups A and B will cross-over the control treatment in order for individual participants in each group to act as their own control.
Control group
Active

Outcomes
Primary outcome [1] 286510 0
changes in serum levels of interleukin 8 (IL-8) inflammatory biomarker previously shown to be elevated in 50 A-T patients compared with controls without A-T (P<.0001) suggesting systemic inflammation contributes to A-T disease characteristics (McGrath-Morrow et al 2010).
Timepoint [1] 286510 0
Timepoint 1 - on enrolment (baseline);
Timepoint 2 - at the end of treatment period 1 (4 weeks wash in period plus 12 weeks) = 16 weeks;
Timepoint 3 - at the end of treatment period 2 (4 weeks washout plus 12 weeks) = 32 weeks
Primary outcome [2] 286511 0
changes in serum levels of quinolinic acid previously identified as a surrogate marker for neurodegeneration based on a role in neurodegenerative disorders Alzheimer's and Huntington's disease (Zwilling et al 2011),
Timepoint [2] 286511 0
Timepoint 1 - on enrolment (baseline);
Timepoint 2 - at the end of treatment period 1 (4 weeks wash in period plus 12 weeks) = 16 weeks;
Timepoint 3 - at the end of treatment period 2 (4 weeks washout plus 12 weeks) = 32 weeks
Secondary outcome [1] 296044 0
Changes in nutritional intake as measured by diet history interview (food composition software will be used to analyse this data in terms of daily averages for intakes of energy, macronutrients, micronutrients and food groups)
Timepoint [1] 296044 0
Timepoint 1 - on enrolment (baseline);
Timepoint 2 - at the end of treatment period 1 (4 weeks wash in period plus 12 weeks) = 16 weeks;
Timepoint 3 - at the end of treatment period 2 (4 weeks washout plus 12 weeks) = 32 weeks.
Follow up at 12 months and 24 months after enrolment.
Secondary outcome [2] 296045 0
Changes in anthropometric measures.
Height and weight will be measured at baseline and 12 and 24 months (BMI and z-scores calculated). Total Body Potassium (TBK) and lean muscle and fat mass (BodPod) will be measured at baseline and 12 and 24 months. Short term changes in weight will be self-reported over the telephone.
Timepoint [2] 296045 0
Timepoint 1 - on enrolment (baseline);
Timepoint 2 - at the end of treatment period 1 (4 weeks wash in period plus 12 weeks) = 16 weeks;
Timepoint 3 - at the end of treatment period 2 (4 weeks washout plus 12 weeks) = 32 weeks.
Follow up at 12 months and 24 months after enrolment.
Secondary outcome [3] 296046 0
changes in quality of life (participants and parents/carers) using the following questionnaires (DASS21; Strengths and Difficulties Questionnaire; satisfaction questionnaire)
Timepoint [3] 296046 0
Timepoint 1 - on enrolment (baseline);
Timepoint 2 - at the end of treatment period 1 (4 weeks wash in period plus 12 weeks) = 16 weeks;
Timepoint 3 - at the end of treatment period 2 (4 weeks washout plus 12 weeks) = 32 weeks.
Follow up at 12 months and 24 months after enrolment.

Eligibility
Key inclusion criteria
Ataxia-telangiectasia diagnosis and attending the National Ataxia Clinic at Royal Brisbane Hospital
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
those without support at home to enable them to follow specific dietary advice;
those who are recieving most or all of their nutrition via PEG

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
unconcealed study.
all participants will receive both treatments on separate occasions during the trial, i e standard nutritional intervention and high antioxidant food-based treatment. The order of treatments for age-matched pairs will be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
pairs of participants will be matched for age and one member of the pair will be randomised to group A or group B (using computer-generated randomisation process). The other member of the pair will be placed in the alternative group.
Group A will follow high antioxidant food-based advice for 12 weeks followed by a 4 week wash out period and followed by standard nutritional advice for 12 weeks.

Group B will follow standard nutritional advice for 12 weeks followed by a 4 week washout period and followed by high antioxidant advice for 12 weeks.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
21/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4995 0
4006

Funding & Sponsors
Funding source category [1] 284701 0
Hospital
Name [1] 284701 0
RBWH Foundation
Country [1] 284701 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane & Women's Hospital
Address
Butterfield Street
Post Office
Royal Brisbane Hospital Queensland 4029
Country
Australia
Secondary sponsor category [1] 283602 0
Hospital
Name [1] 283602 0
Royal Children's Hospital
Address [1] 283602 0
Herston Road
Herston Qld 4006
Country [1] 283602 0
Australia
Other collaborator category [1] 260540 0
University
Name [1] 260540 0
University of Queensland Centre for Clinical Research
Address [1] 260540 0
Herston Road
Herston Qld 4006
Country [1] 260540 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286704 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 286704 0
Herston Road
Herston Qld 4006
Ethics committee country [1] 286704 0
Australia
Date submitted for ethics approval [1] 286704 0
31/01/2012
Approval date [1] 286704 0
Ethics approval number [1] 286704 0
HREC/12/QRBW/37

Summary
Brief summary
1. The overall aim is to provide nutritional intervention as part of the multi-disciplinary management of A-T patients attending the national clinic.

2. To evaluate the effectiveness of standard nutritional advice and standardised supplements for improving intakes and outcomes in A-T.

3. To implement a randomised controlled age-matched cross-over trial design to evaluate the efficacy of a conjunctive anti-oxidant therapy using whole food ingredients to limit or reduce oxidative stress and improve outcomes in A-T.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33769 0
Address 33769 0
Country 33769 0
Phone 33769 0
Fax 33769 0
Email 33769 0
Contact person for public queries
Name 17016 0
Dr Lynda Ross
Address 17016 0
Advanced Accredited Practising Dietitian,
Department of Nutrition & Dietetics,
Level 2, Dr James Mayne Building,
Royal Brisbane & Women's Hospital
Butterfield Street
Post Office
Royal Brisbane Hospital Queensland 4029
Country 17016 0
Australia
Phone 17016 0
+61 07 3636 2351
Fax 17016 0
Email 17016 0
[email protected]
Contact person for scientific queries
Name 7944 0
Prof Martin Lavin
Address 7944 0
Queensland Institute of Medical Research
Herston Road
Herston Qld 4006
Country 7944 0
Australia
Phone 7944 0
+61 07 3362 0341
Fax 7944 0
+61 07 3636 0896
Email 7944 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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