There is a lot of interest in the mental health and wellbeing of women who are pregnant.
Micronutrient Trial for Pregnant Women: Trial Information
What is the purpose of this study?
The Mental Health and Nutrition Research Group at the University of Canterbury are conducting a study to see whether a vitamin and mineral (micronutrient) formula can help pregnant women better deal with stress, anxiety, low or difficult moods.
What products are being used in the study?
The product used in this study is called Daily Essential Nutrients (DEN) (the same product used in the NOMAD trial). Ingredients for DEN can be found in the Information for General Practitioners page. DEN contains a blend of various vitamins, minerals, anti-oxidants, also known as micronutrients.
In order to determine whether or not the micronutrients work, outcomes of those taking the nutrients will be compared to those taking an iodine supplement.
Both products are taken orally in capsule form, usually at a dose of 4 capsules, three times a day. They both contain the New Zealand Minstry of Health recommendation of supplemental iodine for pregnant and lactating women.
What does the study involve?
Women enrolled in the study will be randomised to take either the micronutrient or iodine supplement for 12 weeks. After 12 weeks, all participants have the opportunity to try out the micronutrients until the arrival of their infant and for up to six months after birth if desired.
Participation in the trial involves meeting with a researcher at the University of Canterbury for 45-90 minutes every four weeks throughout pregnancy and three times during the baby’s first 12 months of life. Appointment times are flexible to suit all.
The study will examine the general health outcomes of infants and will also give participants the opportunity to have the development of their infant assessed from birth until 6 months.
Mental health oversight throughout the pregnancy will be provided to all women who participate in the trial.
Who is eligible to take part?
We are looking for pregnant women who are:
- 19 years of age or older
- 12-24 weeks pregnant
- Having one baby
- Living in the Canterbury region
- Feeling stressed, irritable, anxious or low in mood
A diagnosis of depression or anxiety is NOT required for entry into this study.
How much does it cost?
Participation in the study does not incur any costs. Both supplements are provided free of charge. Participants will be given a $10 petrol voucher to reimburse transport costs for each visit to the university. A hamper package will also be gifted once baby has arrived.
How do I take part?
If you’re interested in taking part, you first need to complete an online questionnaire to assess your eligibility.
The questionnaire can be found on the following link and should take approximately 10 minutes to complete. Contact details for the researchers can also be found by following the link.
After completing the survey, a researcher will contact you regarding your eligibility to participate in the trial.
This study has received ethical approval by the Southern Health and Disabilities Ethics Committee and the Standing Committee On Therapeutic Trial (MedSafe). The study has also received approval from the Human Ethics Committee and Ngāi Tahu Consultation and Engagement Group at the University of Canterbury and the reseach committee at the New Zealand College of Midwives.