Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000421235
Ethics application status
Approved
Date submitted
19/05/2009
Date registered
9/06/2009
Date last updated
12/11/2018
Date data sharing statement initially provided
12/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of a nutritional supplement on weight gain after initiation of atypical antipsychotic medication in Early Psychosis patients.
Scientific title
Effects of a nutritional supplement on weight gain after initiation of atypical antipsychotic medication in Early Psychosis patients.
Secondary ID [1] 878 0
2009/036
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Psychosis 4815 0
Condition category
Condition code
Mental Health 237157 237157 0 0
Psychosis and personality disorders
Diet and Nutrition 237158 237158 0 0
Other diet and nutrition disorders
Mental Health 237247 237247 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this project is to see if daily 2g oral capsule dose of Omega 3 supplement will improve the participants ability to minimise any possible weight gain that may occur when taking antipsychotic medication. The oral capsules will be taken once daily when the participants take there medically prescribed medication. To meet the 2g dose amount participants are required to take 4 oral capsule daily (at one time) as each capsule only contains 500mg of active ingredient.

We are proposing that the use of this dose Omega 3 will reduce the participants appetite and help with any possible rapid weight gain. Currently this is a new field of research and no one has tested this idea with young people who are taking antipsychotic medications for the first time. The evidence does show that many young people who start antipsychotic medications gain weight and then stop taking the medication, placing them at greater risk of getting sick again. Weight gain on antipsychotic medications is usually the most rapid during the start of treatment and in the first few weeks of starting medication. This study aims to test if using a product that is widely available with little known side effects can assist with minimising any possible weight gain that may occur on antipsychotic medications.
The nutritional supplement has been widely researched in other areas of health and has been shown to improve mood. No known side effects of the nutritional supplemnt has been documented. The nutritional supplement is widely available in stores and without prescription.

Each person will be asked to participate for 14 weeks in total. The first group (participants are randomly assigned to either group 1 or 2) will start on the active ingredient for 6 weeks then go onto the placebo for 8 weeks (allowing a 2 week wash out period post active ingredient). The second group will start on the placebo for 8 weeks (which is 6 weeks on placebo and then 2 weeks wash out ahead of starting the active tablets - just for consistency in the length of the trial (total 14 weeks for both groups) and then start the active ingredients for the remaining 6 weeks.

Every two weeks either the nutritional supplement or the placebo will be provided by the treating doctor.
Intervention code [1] 4589 0
Prevention
Intervention code [2] 4590 0
Treatment: Drugs
Comparator / control treatment
a placebo medication that contains olive oil and no active ingredient. The plcebo's dose and talets are the same as the active ingredients. that is, each participant will be required to take 4 capsules daily at the same time that they take their medically prescribed medication.

The placebo capsules are the same size and colour as the active capsules and the administarion will be identical.
Control group
Placebo

Outcomes
Primary outcome [1] 237975 0
The primary objective is to establish if the use of the nutritional supplementation at the commencement of atypical antipsychotic medication can reduce weight gain in young people with early psychosis and assist in minimising rapid weight gain associated with these medications.

the methods of assessment includes, clincial psychological assessments of mental state and compliance (routine assessments already completed at service) , blood test to look at compliance of supplement, a food history and food diary record and weight/ body mass index (BMI) measurements. All these measurements (and the same measurements) are taken at baseline, crossover and end point.
Timepoint [1] 237975 0
weight gain measures at start, cross over and end point
Secondary outcome [1] 242086 0
A secondary aim is to see whether the intervention improves compliance with treatment as a result of reduced weight gain. The indirect nature of the effect requires that it be relegated to a secondary status in this small project.

As stated above:

the methods of assessment includes, clincial psychological assessments of mental state and compliance (routine assessments already completed at service) , blood test to look at compliance of supplement, a food history and food diary record and weight/ body mass index (BMI) measurements.
Timepoint [1] 242086 0
compliance at start, cross over and end point

Eligibility
Key inclusion criteria
Are accepted in to the Early Psychosis service at Princess Alexandra Hospital, Division of Mental Health.

Are aged between 18 and 25 years.
Have a family member/ carer/ significant other who is able to participate in the study to provide a history of food behaviours and changes...

Have not been on any antipsychotic medication for greater than 4 weeks.

Not currently underweight (less than 18 body mass index (BMI))
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Outside nominated age range

No family member/ significant other who can participate in diet history

Underweight (less than 18 BMI)

Established on antipsychotic medication

Not able to understand written consent form

Already taking fish oil

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
31/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 1710 0
4122

Funding & Sponsors
Funding source category [1] 4977 0
University
Name [1] 4977 0
Queensland University of Technology
Country [1] 4977 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Queensland Univerity of Technology
Institute of Health and Biomedical Innovation (ihbi)
Level 3, 5 School Street
Kelvin Grove Urban Village
Kelvin Grove, Queensland, 4059
Country
Australia
Secondary sponsor category [1] 4501 0
Hospital
Name [1] 4501 0
Princess Alexandra Hospital
Address [1] 4501 0
519 Kessels Road
MacGregor 4122
Queensland
Country [1] 4501 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 7080 0
Princess ALexandar Hopsital Helath Service District Ethics Committee
Ethics committee address [1] 7080 0
Ethics committee country [1] 7080 0
Australia
Date submitted for ethics approval [1] 7080 0
Approval date [1] 7080 0
26/03/2009
Ethics approval number [1] 7080 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29621 0
Address 29621 0
Country 29621 0
Phone 29621 0
Fax 29621 0
Email 29621 0
Contact person for public queries
Name 12868 0
Carina Capra
Address 12868 0
519 Kessels Road
MacGrgeor
Country 12868 0
Australia
Phone 12868 0
+61 7 3167 8444
Fax 12868 0
Email 12868 0
[email protected]
Contact person for scientific queries
Name 3796 0
Carina Capra
Address 3796 0
519 Kessels Road
MacGrgeor
Country 3796 0
Australia
Phone 3796 0
+61 7 3167 8444
Fax 3796 0
Email 3796 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.