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11 February 2012
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| [ Print-friendly version ] |
| The effects of nutritional supplementation on premenstrual syndrome (PMS) |
| ISRCTN | ISRCTN48058420 |
| ClinicalTrials.gov identifier | |
| Public title | The effects of nutritional supplementation on premenstrual syndrome (PMS) |
| Scientific title | |
| Acronym | PMS study |
| Serial number at source | ECN-04-208 |
| Study hypothesis | 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. |
| Lay summary | |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | Australia |
| Disease/condition/study domain | Pre-menstrual syndrome |
| Participants - inclusion criteria |
1. Subject has a regular menstrual cycle of 25 to 35 days
2. Subject is aged over 18 and less than 45 years 3. Subject’s general health is normal 4. Subject has had symptoms of PMS in the last year 5. Subject is willing to cease taking other supplements for the period of the trial 6. Subject is willing to comply with the study protocol |
| Participants - exclusion criteria |
1. Subject is currently pregnant or lactating
2. Subject who is of childbearing age who is not surgically sterile, who is: a. Not using effective contraception b. 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 |
| Anticipated start date | 01/09/2004 |
| Anticipated end date | 30/10/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 120 women in cohort A and 20 women in cohort B |
| Interventions | The active group is taking calcium and magnesium, and a multivitamin and mineral supplement and control will take 2 placebo tablets; one will be the same size and shape as the calcium and magnesium supplement, and the second will be the same size and shape as the multivitamin and mineral supplement and contain sufficient riboflavin to maintain blinding. |
| Primary outcome measure(s) |
The primary outcome measure for PMS is the Premenstrual Symptom Complex Score, (derived from the Menstrual Health Questionnaire). This is assessed from the means of 23 daily individual symptom ratings and is calculated as shown below.
Luteal Phase Score – Follicular Phase Score x 100 Luteal Phase Score Efficacy is defined as a 20% difference between the premenstrual symptom complex score of those on either of two different dietary supplements compared to those on the placebo. Subjects will record these details in a daily diary. |
| Secondary outcome measure(s) | No secondary outcome measures |
| Sources of funding | Swisse Vitamins Pty Ltd (Australia) |
| Trial website | |
| Publications | |
| Contact name | Dr Joan O'Connor |
| Address | P.O. Box 157 |
| City/town | Lismore |
| Zip/Postcode | 2480 |
| Country | Australia |
| Tel | +61 (0)2 66 20 3649 |
| Fax | +61 (0)2 66 20 3307 |
| joconnor@scu.edu.au | |
| Sponsor | Swisse Vitamins Pty Ltd (Australia) |
| Address |
36-38 Gipps Street
Collingwood |
| City/town | Melbourne |
| Zip/Postcode | 3066 |
| Country | Australia |
| Sponsor website: | http://www.swisse.com.au |
| Date applied | 02/06/2005 |
| Last edited | 14/09/2009 |
| Date ISRCTN assigned | 21/09/2005 |
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