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.: PACTR202105854949466 Date of Approval: 24/05/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Broad spectrum micronutrient supplementation in the management of ADHD symptoms: a clinical trial
Official scientific title Broad spectrum micronutrient supplementation in the management of ADHD symptoms: a clinical trial
Brief summary describing the background and objectives of the trial Attention deficit hyperactivity disorder (ADHD) is the most common neuropsychiatric disorder in children. Its treatment includes behavior therapy with or without pharmacotherapy, with the former being less efficacious. Pharmacotherapy is associated with about 0.54 effect size on hyperactivity indices as reported by parents and is not necessarily a panacea for all the symptoms of ADHD. It’s also associated with serious adverse events, occurring in 1.2% of participants in a Cochrane review of randomized control trials, while more than half of the participants suffered one or more adverse events. In a critical review on the use of non-pharmacologic supplementation in children and adolescents with ADHD, carried out in 2020, 13 out of 20 randomized control trials on use of polyunsaturated fatty acids in ADHD showed improvements in symptomatology and all of the five trials done on use of combinations of vitamins and minerals showed cognitive, behavioral and emotional improvements in ADHD symptoms. Our study aims to use broad spectrum micronutrients (a combination of multivitamins, minerals and polyunsaturated fatty acids), which has not been previously explored, hence providing data on the additional benefits of this combination. Our primary objective is to evaluate the efficacy of broad spectrum micronutrients on hyperactivity and inattentive symptoms on patients 6 to 13 years of age with ADHD who are not on pharmacotherapy over 12 weeks’ duration.
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 Treatment: Drugs
Anticipated trial start date 01/07/2021
Actual trial start date
Anticipated date of last follow up 30/10/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
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
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Centrum Kids and Sundown omega 3 gel One multivitamin/multimineral supplement and one omega 3 gel given once a day 12 weeks Centrum Kids multivitamin/multimineral supplement is a supplement that consists of a combination of 23 vitamins and minerals. Compared to other locally available mineral, multivitamin and omega 3 formulations, the intervention has levels of minerals and multivitamins that are on the upper range of the recommended dietary allowance but are lower than the tolerable upper intake level. This enables us to reproduce the dosages used in similar studies where higher levels of the multi-nutrients were used but avoid the adverse effects associated with levels greater than the tolerated upper intake levels. Sundown omega 3 gel consists of gels containing 900mg of omega 3 in each gel. 15
Control Group No intervention N/A 12 weeks Participants in the control group will not receive any intervention 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Children 6 to 13 years of age with a diagnosis of ADHD made by a child psychiatrist using the DSM-5 criteria 2. Patients who are not on pharmacotherapy having been initiated on behavioral therapy as a first step in care or patients who have previously been on pharmacotherapy but have since stopped use, at least one month before consideration for recruitment, because of insufficient response or intolerance to side effects. 3. Informed written consent to participate in the study 1. Patients on pharmacotherapy 2. Patients already on multivitamin/ PUFA supplementation 3. Patients with co-existing Autism Spectrum Disorder (ASD) and/or Epilepsy Child: 6 Year-12 Year 6 Year(s) 13 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 07/04/2021 Aga Khan University Nairobi Institutional Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
P.O. BOX 30270 Nairobi 00100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Hyperactivity and inattentiveness rating in response to the intervention, monitored using the Conners Parent Rating Scale- Revised Long Form, as reported the parents At onset of study and at 12 weeks
Secondary Outcome Severity and improvement of hyperactivity and inattentiveness graded by the clinician using the Clinical Global Impression Scales. The Clinical Global Impression Scale-Severity (CGI-S) at the onset of the study to assesses severity of the illness and a Clinical Global Impression Scale- Improvement (CGI-I) at 6 weeks and 12 weeks so as to rate the change from initiation of treatment. 0,6 and 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kenyatta National Hospital Nairobi Nairobi Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Self funded Nairobi Nairobi Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Maureen Njoroge 30270 Nairobi 00100 Kenya Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Maureen Njoroge drmuthoninjoroge@gmail.com +254723448424 30270
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Child Neurology fellow
Role Name Email Phone Street address
Public Enquiries Samson Gwer samgwer@gmail.com +254722260437 43844
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Pediatric Neurologist
Role Name Email Phone Street address
Scientific Enquiries Pauline Samia pauline.samia@aku.edu +254722871067 30270
City Postal code Country Position/Affiliation
Nairobi 00100 Kenya Pediatric neurologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be made available and accessible within 3 months of publication. The study protocol and statistical analysis plan will also be made available. The data will be accessible to researchers for analysis or meta-analysis. This will be made possible via a link that will be shared after publication to access the data. Statistical Analysis Plan,Study Protocol within 3 months after publication Researchers, for analyses and meta-analyses
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