None listed
Conditions
Brief summary
Calcium and magnesium in the form of a specific mineral supplement will reduce symptoms of premenstrual syndrome by 20% after 4 months of daily use. This calcium and magnesium supplement used in conjunction with a combination of micronutrients in the form of a specific multi vitamin, mineral and herbal tablet will reduce the symptoms of premenstrual syndrome by 30 % after 4 months of daily use.The study also seeks to compare differences in bone densitometry parameters in women with and women without PMS. To achieve this aim 2 cohorts of subjects will be enrolled, Cohort A will be an initial enrolment of 180 women with self-report of PMS. (This number will allow for 30% exclusion due to insufficient premenstrual symptom score at visit 2). Cohort B will be an enrolment of 40 women who do not have PMS after assessment with Menstrual Health Questionnaire (This number will allow for 50% exclusion/drop out at visit 2).
Interventions
STUDY TREATMENT ARMS
Group1: Calcium and magnesium and a placebo tablet
Group 2: Calcium and magnesium and a multivitamin and mineral tablet
Sponsors
Swisse Bio-juven
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Subject has a regular menstrual cycle of 25 to 35 days. 2. Subject's general health is normal. 3. Subject has had symptoms of PMS in the last year. 4. Subject is willing to cease taking other supplements for the period of the trail. 5. Subject is willing to comply with the study protocol.
Exclusion criteria
1. Subject is currently pregnant or lactating. 2. Subject who is of childbearing age who is not surgically sterile, who is 1) not using effective contraception, and 2) does not agree to have a pregnancy test monthly during the study. 3. Subject is currently taking regular medication or dietary supplement(s) and is unwilling to cease. 4. Subject self reports that they are experiencing undue stress/relationship problems. 5. Subject has any significant disease or disorder. 6. Subject is currently undergoing treatment for PMS. 7. Subject commenced oral contraceptives in the three months prior to commencement. 8. Subject changed oral contraceptives in the three months prior to commencement. 9. Subject has had adverse effects from supplements and/or drugs. 10. Subjects who are taking steroids. 11. Subjects with parathyroid disorders. 12. Subjects with thyroid disorders. 13. Subjects with affective disorders. 14. Subjects who experience photosensitive skin reactions or hypersensitivity to ginger. 15. Any disease particularly conditions that interact with gonadotrophins or their releasing factors and those that compromise digestion or absorption of micronutrients. 16. Any significant health complaint, problem or disease that in the opinion of the researcher would compromise the study.
Outcome results
None listed