None listed
Conditions
Brief summary
This study aims to look at the effect that a micronutrient formula (vitamins and minerals) has on premenstrual symptoms. The efficacy of this formula is to be compared to an already validated premenstrual syndrome (PMS) treatment, vitamin B6. Previous research has shown that combinations of nutrients, like those found in the micronutrient formula, can lower symptoms of stress, mood, and anxiety. Since these symptoms are often reported in PMS, it is hypothesised that the micronutrient formula will decrease overall symptoms, producing a greater measurable effect than by using vitamin B6 alone.
Interventions
Participants will be randomly assigned to receive either the vitamin B6 treatment or the micronutrient formula. In both treatment groups they will be asked to take a total of eight capsules per day; four in the morning, four in the afternoon/evening with plenty of food and water. Treatment adherence will be monitored through the return of unused pills at the beginning of each month. The treatment phase will last for a total of three months.
Women assigned to the micronutrient formula will take a
Participants will be randomly assigned to receive either the vitamin B6 treatment or the micronutrient formula. In both treatment groups they will be asked to take a total of eight capsules per day; four in the morning, four in the afternoon/evening with plenty of food and water. Treatment adherence will be monitored through the return of unused pills at the beginning of each month. The treatment phase will last for a total of three months. Women assigned to the micronutrient formula will take a blend of vitamins and minerals in the supplement EMPowerplus Advanced. This formula will be provided by Truehope located in Raymond, Alberta, Canada. The dose and ingredients are as follows: Vitamin A (as retinyl palmitate), 3072 IU, Vitamin C (as ascorbic acid) 320mg, Vitamin D (as cholecalciferol), 768 IU, Vitamin E (as d-alpha tocopheryl succinate) 192 IU, Thiamin (as thiamin mononitrate) 9.6mg, Riboflavin 7.2mg, Niacin (as niacinamide) 48mg, Vitamin B6 (as pyridoxine hydrochloride) 19.2mg, Folic acid 768mcg, Vitamin B12 (as methylcobalamin) 480mcg, Biotin 576mcg, Pantothenic acid (as calcium pantothenate) 11.52mg, Calcium (as chelate) 704mg, Iron (as chelate) 7.328mg, Phosphorus (as chelate) 448mg, Iodine (from Pacific kelp) 108.8mcg, Magnesium (as chelate) 320mg, Zinc (as chelate) 25.6mg, Selenium (as chelate) 108.8mcg, Copper (as chelate) 3.84mg, Manganese (as chelate) 5.12mg, Chromium (as chelate) 332.8mcg, Molybdenum (as chelate) 76.8 mcg, Potassium (as chelate) 128mg, Choline bitartrate 288mg, DL-phenylalanine 192mg, Bioflavonoids 128mg, Inositol 96mg, L-Glutamine 96mg, L-Methionine 32mg, Grape seed extract 24mg, Gingko biloba leaf extract 19.2mg, Germanium sesquioxide 11.04mg, Boron (as chelate) 1.28mg, Vanadium (as chelate) 0.6368mg, and Nickel (as chelate) 15.68mcg. Other ingredients: capsule shell (gelatin, titanium dioxide) microcrystalline cellulose, glycine, citric acid, magnesium stearate, silicon dioxide, mineral wax. The values given are based on a consumption of eight capsules per day.
Sponsors
University of Canterbury
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
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For inclusion participants must be regularly menstruating females over the age of 18 (cycle length must last between 21-35 days) who have premenstrual syndrome (PMS) as determined by information given on the Daily Record of Severity of Problems questionnaire.
Exclusion criteria
Cannot be pregnant or planning to become pregnant, no accompanying major mood disorder, cannot currently be taking medication for premenstrual syndrome (PMS). Participants with any of the following will be excluded: 1) neurological disorder involving brain or other central nervous system function (e.g., epilepsy), 2) pregnant or breastfeeding, 3) evidence of untreated or unstable thyroid disease, 4) any known abnormality of mineral metabolism (e.g., Wilson’s disease, haemochromatosis), 5) judged clinically to be at serious risk of suicide or violence, or 6) currently taking any other medication with primarily central nervous system activity.
Outcome results
None listed