None listed
Conditions
Brief summary
This study aims to compare the effect of a multi-nutrient formula to an active control on symptoms of depression and anxiety in pregnant women who are symptomatic. Given the association between nutritional deficiencies and depression during pregnancy and previous research showing that multi-nutrients can improve mood and anxiety, this study hypothesises that a multi-nutrient formula will reduce symptoms of depression and anxiety during pregnancy more so than an active control.
Interventions
Multi-nutrient formula
Participants will be randomly assigned to receive either a multi-nutrient formula or an active control for twelve weeks. After twelve weeks, all participants will enter into an open-label phase where they can choose to take the multi-nutrient formula until the birth of their child. Both the multi-nutrient formula and the active control are in capsule form and are to be taken orally at a dose of 12 capsules per day; four capsules taken three times per day with food and wate
Multi-nutrient formula Participants will be randomly assigned to receive either a multi-nutrient formula or an active control for twelve weeks. After twelve weeks, all participants will enter into an open-label phase where they can choose to take the multi-nutrient formula until the birth of their child. Both the multi-nutrient formula and the active control are in capsule form and are to be taken orally at a dose of 12 capsules per day; four capsules taken three times per day with food and water. The multi-nutrient formula and active control adhere to the New Zealand Ministry of Health recommendation for the daily intake of iodine for pregnant and lactating women. The multi-nutrient intervention is a blend of vitamins, minerals, antioxidants and amino acids. The formula, Daily Essential Nutrients, is being manufactured and donated by Hardy Nutritionals (Registered Trademark), Canada and consists of the following ingredients. The following doses are for 12 capsules (full dose per day): Vitamin A (as retinyl palmitate), 5,760 IU; Vitamin C (as ascorbic acid), 600 mg; Vitamin D (as cholecalciferol), 3,000 IU; Vitamin E (as d-alpha tocopheryl succinate), 360 IU; Vitamin K (75% as phylloquinone; 25% as menaquinone-7), 120 mcg; Thiamin (as thiamin mononitrate), 60 mg; Riboflavin, 18 mg; Niacin (as niacinamide), 90 mg; Vitamin B6 (as pyridoxine hydrochloride), 69.9 mg; Folate (as L-methylfolate calcium), 801 mcg; Vitamin B12 (as methylcobalamin), 900 mcg; Biotin, 1080 mcg; Pantothenic acid (as d-calcium pantothenate), 30 mg; Calcium (as chelate), 1,320 mg; Iron (as chelate), 13.8 mg; Phosphorus (as chelate), 840 mg; Iodine (as chelate), 204 mcg; Magnesium (as chelate), 600 mg; Zinc (as chelate), 48 mg; Selenium (as chelate), 204 mcg; Copper (as chelate), 7.2 mg; Manganese (as chelate), 9.6 mg; Chromium (as chelate), 624 mcg; Molybdenum (as chelate), 144 mcg; Potassium (as chelate), 240 mg. Proprietary blend: Choline bitartrate, Alpha-lipoic acid, Mineral wax, Inositol, Acetyl-L-carnitine, Grape seed extract, Ginkgo biloba leaf extract, L-methionine, N-acetyl-L-cysteine, Boron, Vanadium, Lithium orotate, Nickel. Other ingredients: Vegetarian capsule (hypromellose), microcrystalline cellulose, magnesium stearate, silicon dioxide, titanium dioxide. Adherence to the intervention will be assessed fortnightly throughout the study period. Participants are required to report the number of capsules missed over a two week period and return any unused capsules to the study investigators every fourth week.
Sponsors
Professor Julia Rucklidge
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) women aged 16 years and over; 2) 12-24 weeks gestation; 3) low risk singleton pregnancy; 4) free from psychiatric medication for four weeks; 5) score of 13 or more on the Edinburgh Postnatal Depression Scale (EPDS); 6) deemed reliable and compliant with the protocol. Reference group inclusion criteria: 1) pregnant women aged 16 years and over; 2) low risk singleton pregnancy
Exclusion criteria
1) regular vomiting; 2) high risk pregnancy; 3) significant pregnancy complications; 4) known foetal abnormalities; 5) serious current or historical medical condition; 6) known allergy to the ingredients of the intervention; 7) known metabolic condition such as Wilson’s disease, hemochromatosis.; 8) untreated or unstable thyroid disease; 9) known neurological disorder; 10) desire to continue taking prenatal supplements that either exceed the upper limit or are not required for medical purposes (decisions discussed and made on a case-by-case basis)
Outcome results
None listed