Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000156381
Ethics application status
Approved
Date submitted
25/01/2017
Date registered
30/01/2017
Date last updated
2/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
An examination of the effects of curcumin for the treatment of attention and impulsivity problems in children and adolescents
Scientific title
Curcumin supplementation for the treatment of attention and impulsivity problems in children and adolescents – a randomised, double-blind, placebo-controlled, crossover study
Secondary ID [1] 290856 0
None
Universal Trial Number (UTN)
U1111-1191-4053
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Attention deficit hyperactivity disorder (ADHD) 301539 0
Condition category
Condition code
Mental Health 301259 301259 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Candies containing curcumin (500mg) of a proprietary blend of curcumin (BCM-95 'Registered Trademark') will be consumed twice daily for 8 weeks by children presenting with significant attentional problems. Adherence to supplementation intake will be monitored through pill return and count. In this crossover trial, there is no washout period between treatment arms.
Intervention code [1] 296798 0
Treatment: Other
Comparator / control treatment
Placebo is matched to the curcumin candies in terms of taste and appearance but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 300671 0
Change in Conners Continuous Performance Test 3rd Edition 'Trademark' (Conners CPT 3 'Trademark")
Timepoint [1] 300671 0
Weeks 0 and 8
Secondary outcome [1] 330565 0
Change in ADHD score as assessed by the ADHD Rating Scale-IV
Timepoint [1] 330565 0
Weeks 0, 2, 4, 6 and 8
Secondary outcome [2] 330566 0
Strengths and Difficulties Questionnaire (SDQ). The SDQ is a behavioral screening questionnaire assessing the following areas- emotional symptoms, conduct problems, hyperactivity/ inattention, peer relationship problems and prosocial behaviour.
Timepoint [2] 330566 0
Weeks 0 and 8
Secondary outcome [3] 330567 0
Revised child anxiety and depression scale (RCADS- short version) (child)
Timepoint [3] 330567 0
Weeks 0 and 8
Secondary outcome [4] 330568 0
Depression, Anxiety, Stress Scale (parent)
Timepoint [4] 330568 0
Weeks 0 and 8

Eligibility
Key inclusion criteria
1. Otherwise healthy males and females aged between 8 and 14 years
2. Diagnosis of ADHD or significant attentional problem
3. Total score on ADHD Rating Scale-IV above clinical cut-off
4. Parents and child fluent in English
5. Parent/legal guardian and child to provide a personally signed and dated informed consent indicating that they have been informed of all pertinent aspects of the trial.
6. Child willing and able to swallow capsules
Minimum age
8 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current or 12-month history in child of any psychiatric disorder other than ADHD
2. Current or 12-month history in child of significant oppositional or conduct-related problems
3. Child is currently taking any pharmaceutical medication (including ADHD medication), apart from the occasional use (no more than fortnightly) of pain-relievers (e.g., ibuprofen, Panadol)
4. Current or history of clinically significant chronic medical condition including cardiovascular disease, organic brain disorder, seizure, diabetes
5. Current abuse or dependence on drugs
6. Any learning problem significantly affecting educational achievement
7. Currently taking curcumin capsules

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)
Participants will be randomly allocated into placebo and treatment groups. These groups are named group 1 and group 2 and the primary investigator and participants will be unaware of which treatment these groups represent. Each participant will be allocated a participant number (1 to 60) based on the order of inclusion in the study. A computer-generated software will randomly assign the numbers 1 to 60 into either group 1 or 2.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In this crossover study, children will be given an opportunity to take both curcumin and placebo. This ensures we have a sample size of 60 in each group. With a predicted moderate effect size of 0.5, this study is sufficiently powered to detect group differences.

Pre and post analyses will be conducted to determine changes in the following:
1. Scores determined from the administration of the Connors Continuous Performance Test
2. Attention and impulsivity scores (ADHD rating scale)
3. Mood and behavioural scores (SDQ and RCADS questionnaires)

Comparisons will be made between the periods when participants were taking a placebo versus periods on curcumin to determine if there are any significant differences in the above measures.

These analyses will be conducted via a repeated measures analysis of variance via SPSS

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The study design was significantly modified and no recruitment occurred. The study has been stopped.
Date of first participant enrolment
Anticipated
13/03/2017
Actual
Date of last participant enrolment
Anticipated
14/09/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 295287 0
Commercial sector/Industry
Name [1] 295287 0
Dolcas-Biotech, LLC
Country [1] 295287 0
United States of America
Primary sponsor type
University
Name
Murdoch University
Address
90 South St, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 294108 0
Commercial sector/Industry
Name [1] 294108 0
Arjuna Natural Extracts Limited
Address [1] 294108 0
PB No : 126,
Bank Road, Alwaye,
Kerala, India
PIN : 683 101
Country [1] 294108 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296622 0
Murdoch University Human Research Ethics Committee
Ethics committee address [1] 296622 0
90 South St
Murdoch WA 6150
Ethics committee country [1] 296622 0
Australia
Date submitted for ethics approval [1] 296622 0
12/12/2016
Approval date [1] 296622 0
25/01/2017
Ethics approval number [1] 296622 0
2016/223

Summary
Brief summary
This is a double-blind, placebo-controlled, crossover study assessing the therapeutic effects of curcumin in 60 youth suffering from attentional problems. Each participant receives both treatments (8 weeks of curcumin and placebo) and randomisation is used to determine the order in which the participant receives each treatment,( i.e. curcumin followed by placebo, or placebo followed by curcumin). The curcumin dosage is 500mg of BCM-95 'Registered Trademark' twice daily. Changes in attentional symptoms will be assessed via a computerised test for attention and the completion of several questionnaires.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71506 0
Prof Peter Drummond
Address 71506 0
Murdoch University, School of Psychology and Exercise Science, 90 South St Murdoch Western Australia 6150
Country 71506 0
Australia
Phone 71506 0
+61 8 9360 2415
Fax 71506 0
Email 71506 0
P.Drummond@murdoch.edu.au
Contact person for public queries
Name 71507 0
Dr Adrian Lopresti
Address 71507 0
Murdoch University, School of Psychology and Exercise Science, 90 South St Murdoch Western Australia 6150
Country 71507 0
Australia
Phone 71507 0
+61411969797
Fax 71507 0
Email 71507 0
a.lopresti@murdoch.edu.au
Contact person for scientific queries
Name 71508 0
Dr Adrian Lopresti
Address 71508 0
Murdoch University, School of Psychology and Exercise Science, 90 South St Murdoch Western Australia 6150
Country 71508 0
Australia
Phone 71508 0
+61411969797
Fax 71508 0
Email 71508 0
a.lopresti@murdoch.edu.au

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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