Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202011697726048 Date of Approval: 11/11/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Methylphenidate physiological and physical performance effects
Official scientific title Methylphenidate: Physiological, neurocognitive, balance, and physical performance effects
Brief summary describing the background and objectives of the trial This study has relevance on the physical performance of patients diagnosed with ADHD in their daily activities, in their sports participation and on implications for doping control regulations. It will further evaluate a number of physiological parameters that are germane to sport such as aerobic fitness, muscle strength, cognitive function, balance, and risks, such as for cardiac events. With the apparent widespread use of MPH amongst athletes, whether for legitimate medical reasons or as a performance enhancing substance; and the prevalent concern of sudden cardiac death in athletes, this study will also address the potential harmful effects of MPH on cardiac electrical activity.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Mental and Behavioural Disorders
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 03/02/2020
Actual trial start date
Anticipated date of last follow up 04/05/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 70
Actual target sample size (number of participants)
Recruitment status Suspended
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Methyphenidate active group 20mg slow release daily 2 weeks Pre-intrevention test battery of outcome measures, then daily dose of drug for two weeks. Thereafter wash out period of 3 days before crossover 35
Control Group Control group Placvebo 2 weeks Pre-intervention test battery, then placebo daily dose for 2 weeks. Three day washout before crossover 35 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Newly diagnosed ADHD children or adults who have not yet started taking the prescribed methylphenidate, or have been drug-naïve for at least 6 months 1. Between the ages of 14- 30 years 2. Participants will be willing to accept that placebo/inactive formulation will be administered for 2 weeks 3. Participants will be willing to volunteer to undergo non-invasive investigations and assessments 1. The use of any other medication that may affect physical performance, electrocardiogram tracings or balance 2. Any physical or other affliction that may affect the successful completion of the physical performance tests Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 14 Year(s) 30 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 13/11/2018 Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
29 Princess of Wales Terrace, Parktown, Johannesburg Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome Anthropometry - height, weight, waist circumference, BMI Pre- and post intervention
Primary Outcome Physiological - ECG, cardiorespiratory fitness, postural balance, muscle strength, psychometry, academic and sport performance Pre-and post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Centre for Exercise Science and Sports Medicine 27 St Andrews Road Johannesburg 2193 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
National Lottery Distribution Trust Fund Block D, Hatfield Gardens 333 Grosvenor Street Hatfield Pretoria 0083 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor National Lottery Distribution Trust Fund Block D, Hatfield Gardens 333 Grosvenor Street Hatfield Pretoria 0083 South Africa Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Demitri Constantinou demitri.constantinou@wits.ac.za +27117173396 Centre for Exercise Science and Sports Medicine, 27 St Andrews Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Adjunct Professor and Director
Role Name Email Phone Street address
Public Enquiries Didintle Shuping didi.shuping@wits.ac.za +27117173372 Centre for Exercise Science and Sports Medicine, 27 St Andrews Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Administrative assistant
Role Name Email Phone Street address
Scientific Enquiries Philippe Gradidge philippe.gradidge@wits.ac.za +27117173372 Centre for Exercise Science and Sports Medicine, 27 St Andrews Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Associate Professor and Research Coordinator
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The indivivdual participant data will be shared after de-identification after completion of the study. Informed Consent Form,Statistical Analysis Plan,Study Protocol The additional documents will be avialble within 6 months of completion of the stauyd and up to a period of 2 years The data will be accessible by controlled means. The PI will allow access based on request, by whom, for and for what purpose.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information