An examination of the effects of curcumin for the treatment of attention and impulsivity problems in children and adolescents

Curcumin supplementation for the treatment of attention and impulsivity problems in children and adolescents – a randomised, double-blind, placebo-controlled, crossover study

Status

Withdrawn

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617000156381

Enrollment

Registered

2017-01-30

Start date

2017-03-13

Completion date

2017-09-14

Last updated

2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender

All

Age

8 Years to 14 Years

Healthy volunteers

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

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

Outcome results