Skeletal muscle cramps Musculoskeletal Diseases
Conditions
Interventions
Participants are randomized to either the active control group (organic magnesium salts) or active treatment group (choline-stabilized orthosilicic acid and organic magnesium salts) using block random
Sponsors
Bio Minerals NV
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent. 2. Males and Females between the ages of 18 years old and 75 years old. 3. Females must use an approved form of birth control or be postmenopausal or be surgically sterile. 4. Skeletal muscle cramps defined as: sudden, involuntary and painful contractions of the skeletal muscles, lasting seconds to minutes and often accompanied by a palpable knotting of the muscle. 5. Cramp frequency of at least 2 cramp days/nights per week in the previous month. 6. Cramp frequency of at least 2 days/nights suffering from cramps in the previous week (between the screening visit and baseline visit). 7. BMI between 18 and 35. 8. Subject must continue his/her normal physical activities during the study i.e. there should be no change in physical activity after the screening visit. 9. Subject has a smartphone/pc/tablet at home and is capable and willing to complete digital questionnaires daily. 10. History of magnesium use for cramp relief without a clear result on cramp symptoms.
Exclusion criteria
Exclusion criteria: 1. Subject unable to understand the study procedures and/or not having given written informed consent and/or not wishing to participate in one of the subsequent therapeutic intervention protocols. 2. Poor general health interfering with compliance or assessment. 3. Unlikely to cooperate fully in the study. 4. Participating in another clinical trial in the last 90 days. 5. Pregnancy or breastfeeding. 6. BMI >35 or BMI <18 kg/m² 7. Recent or current alcohol abuse (consumption levels of more than 28 units per week) and drug abuse. 8. Subjects with documented, active infection diseases such as HIV, hepatitis B/C. 9. Clinically significant medical abnormalities which would make the subject unsuitable for the study, as judged by the investigator, such as mental disorders. 10. Subject with current active treatment for renal failure or cancer. 11. Subject with documented history of stroke or myocardial infarct. 12. Subject without a history of magnesium use for cramp relief. 13. Subject with a history of magnesium use for cramp relief with a clear result on cramp symptoms. 14. New physical activity i.e. physical activity which was not present prior to the screening visit. 15. Concomitant and previous medication: 15.1. Treatment with quinine sulfate: wash-out period of 1 week before the screening visit. 15.2. Supplementation with food supplements containing horsetail extract, bamboo extract, silicic acid or silanol derivatives: wash-out period of 3 months before the screening visit. 15.3. A change in the use of other therapies (except quinine sulfate) which may affect the number of cramps episodes (e.g. physiotherapy, calcium channel blockers, Vitamin E and B, diuretics, laxatives, beta-agonists, proton pump inhibitors, muscle relaxants) within 4 weeks before the screening visit or during the complete study period is not allowed. Exception: Magnesium supplementation, if used stable for at least 4 weeks before the screening visit, should be continued up until the baseline visit (T0 visit). At the baseline visit (T0 visit) the Mg supplement will be replaced by the study dietary supplement (Mg or CS-OSA-Mg).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of cramp episodes per week measured using a daily digital cramp diary over 1 week without treatment and 6 weeks with treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain severity of cramp episodes measured using a daily digital cramp diary over 1 week without treatment and 6 weeks with treatment 2. Duration of cramp episodes measured using a daily digital cramp diary over 1 week without treatment and 6 weeks with treatment 3. Sleep disturbances because of cramps measured using a daily digital cramp diary over 1 week without treatment and 6 weeks with treatment 4. Number of days/nights without cramps measured using a daily digital cramp diary over 1 week without treatment and 6 weeks with treatment 5. Quality of life measured using the acute SF36v2 questionnaire at baseline and 6 weeks 6. Quality of sleep measured using the acute MOS-SS questionnaire at baseline and 6 weeks 7. Biomarkers of collagen metabolism measured using serum and urine samples at baseline and 6 weeks 8. Biomarkers of muscle damage measured using serum and urine samples at baseline and 6 weeks | — |
Countries
Belgium, Czech Republic
Contacts
Public ContactMattias Bonnarens
Outcome results
None listed