Micronutrients for mental health: NZ researchers hopeful that world-first RCTs will revolutionise treatment
The researchers, who are from the University of Canterbury, believe ample and regular doses of vitamins and minerals are likely to result in fewer side effects than conventional medication, and are therefore attempting to provide scientific evidence to support the viability of alternative treatment for these conditions.
To do so, they are currently recruiting participants for two trials — one for the general public, called Nutrients for Mental Health, Anxiety and Depression (NoMAD), and another for pregnant women.
Leading the research team is Julia Rucklidge, a professor of clinical psychology at the university.
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Mothers and others
She told NutraIngredients-Asia: "For the general public study, we are looking to recruit 200 individuals who are suffering from anxiety and depression.
"This a double-blind, placebo-controlled RCT that will be conducted in a community setting over 10 weeks, whereby participants will be randomised to receive either micronutrient treatment or a placebo.
"After that, all participants will have the chance to receive the treatment for another 10 weeks."
She added that participants must be above 18 years old, and must not be medicated for their symptoms.
The other trial, which will assess the effects of micronutrient supplementation on anxiety in pregnant women, has a recruitment target of 120 women aged 19 and above, with single pregnancies of between 12 and 24 weeks.
Rucklidge said, "There will first be a 12-week randomisation phase, where the women will receive either capsules containing a broad spectrum of active micronutrients, or capsules containing nutrients like iodine, which are recommended by the Ministry of Health.
"Like the general study, participants in this RCT will have the opportunity after the randomisation phase to take the micronutrient formula for another 12 weeks, or until they give birth.
"We will follow up with them every four weeks throughout the trial, and their mental health will be assessed throughout their pregnancies."
The micronutrient formulation used in the trials, simply called Daily Essential Nutrients, provided by US-based Hardy Nutritionals.
According to the company, the formulation has been clinically tested by both independent and university researchers, with a recent study reporting on its efficacy against childhood ADHD.
The formulation consists of 40 ingredients found in everyday food, such as B vitamins, vitamins C and D, and minerals like iodine, iron and zinc — albeit in much higher concentrations.
While Hardy Nutritionals provides the micronutrients and placebo free of charge to the team, funding for the study comes entirely from independent sources.
Recruitment and reasoning
Rucklidge revealed that the team had started recruitment for NoMAD three months ago, with 15 participants currently enrolled. The study is expected to be completed within a year and a half.
The trial involving pregnant women, on the other hand, has been experiencing a much slower recruitment process — though it began last year, only 35 women have been enrolled so far. Its projected completion will likely be in two years' time.
Regarding the rationale behind the trials, Rucklidge explained: "We already have a lot of clinical trials on nutrients' effects on people with dysregulated moods, and anxiety symptoms.
"However, we've never targeted the symptoms directly before, so the purpose of these trials are to do so and see if we can provide sufficient evidence that may lead to the development of alternative treatment using micronutrients.
"For pregnant women in particular, the options for those struggling with such symptoms are very limited. It was actually surprising for us to learn that there hadn't been any clinical trials done on the effects of nutrient intake on women who are depressed during pregnancy.
"So this seems like a reasonable course of action at this point. If the results are positive, it would mean a new and possibly better approach to treating mental illness."