RecruitingPhase 3ACTRN12605000364673

The effects of nutritional supplementation on premenstrual syndrome


Sponsor

Swisse Bio-juven

Enrollment

120 participants

Start Date

Jan 6, 2004

Study Type

Interventional

Conditions

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).


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether daily calcium and magnesium supplements, with or without a multi-vitamin and herbal tablet, can reduce the symptoms of premenstrual syndrome (PMS). PMS causes physical and emotional symptoms (such as bloating, mood changes, and cramps) in the days before a period. Researchers also want to compare bone density between women with and without PMS. Women will take supplements daily for 4 months and report changes in their symptoms. You may be eligible if: - You are a female between 18 and 45 years old - You have a regular menstrual cycle of 25 to 35 days - You have had PMS symptoms in the last year - You are in generally good health - You are willing to stop taking other supplements for the duration of the study You may NOT be eligible if: - You are currently pregnant or breastfeeding - You are of childbearing age, not using effective contraception, and not willing to take monthly pregnancy tests - You are currently being treated for PMS - You have started or changed oral contraceptives within the last 3 months - You have a thyroid, parathyroid, or mood disorder - You have a significant health condition - You are under a lot of stress or experiencing serious relationship problems Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

STUDY TREATMENT ARMS Group1: Calcium and magnesium and a placebo tablet Group 2: Calcium and magnesium and a multivitamin and mineral tablet

STUDY TREATMENT ARMS Group1: Calcium and magnesium and a placebo tablet Group 2: Calcium and magnesium and a multivitamin and mineral tablet


Locations(1)

Australia

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ACTRN12605000364673


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