The effects of nutritional supplementation on premenstrual syndrome (PMS)

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2005
INTERVENTION: 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. CONDITION: Pre‐menstrual syndrome ; Urological and Genital Diseases ; Premenstrual syndrome (PMS) PRIMARY OUTCOME: 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: No secondary outcome measures 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
Epistemonikos ID: 15098fdbe6277cdcbf643b14a26f0f7689e2b501
First added on: Aug 21, 2024