Protocol No: ECCT/21/05/04 Date of Protocol: 18-05-2021

Study Title:

Broad spectrum micronutrient supplementation in the management of ADHD symptoms:a clinical trial

Study Objectives:

To evaluate the effect of broad spectrum micronutrients on hyperactivity and inattentive symptoms on patients 6 to 13 years of age with ADHD over 12 weeks’ duration.

Laymans Summary:

Attention deficit hyperactivity disorder (ADHD) is the most common neuropsychiatric disorder in children. Treatment includes use of behavior therapy, which is use of methods to strengthen positive behavior and eliminate negative behavior,  with or without the use of medication. Medication works more effectively compared to behavior therapy but it it associated with harmful, unwanted effects in more than half of those who use it. Use of multivitamins, minerals  and omega 3 have been shown to individually show improvements in symptoms of ADHD. 

This paper aims to investigate how effective broad spectrum micronutrients (multivitamins, minerals and omega 3) are in management of inattentiveness and hyperactivity in patients who are 6 to 13 years of age with ADHD, and who do not qualify to be on pharmacotherapy, over 12 weeks duration
Abstract of Study:

Background

Attention deficit hyperactivity disorder (ADHD) is the most common neuropsychiatric disorder in children. 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, with similar efficacy in both long acting and short acting forms, and is not necessarily a panacea for all the symptoms of ADHD. It is 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.

Interventional trials done on the use of broad spectrum micronutrients (multivitamins, minerals and polyunsaturated fatty acids) have demonstrated improvement in ADHD symptoms in children, with two trials showing improvements in one third of children with inattentive symptoms.

Justification

Malnutrition with multiple micronutrient deficiencies is common and may impact the symptomatology of ADHD in our setting.

Micronutrients present a safe and scalable treatment option. Despite showing promising evidence as a treatment modality for ADHD, only a handful of studies have been done on their use.

Objectives

The 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 do not qualify to be on pharmacotherapy over 12 weeks’ duration.

Method

The study is an open-label randomized controlled trial. Patients on behavior therapy meeting inclusion criteria will be recruited from Kenyatta National hospital child psychiatry clinic and randomized into two arms: broad spectrum micronutrients and no micronutrient therapy. The intervention will be Centrum Kids Chewables Multivitamin/ Multimineral supplement and Sundown omega 3 gel. Related clinical data will be collected using a structured questionnaire, and outcomes assessed using the Conner’s Parent Rating Scale-Revised Long Form and the Clinical Global Impression Scales. Continuous and discrete variables will be analyzed using appropriate parametric and non-parametric tests.