Multicentre, randomised, triple-blind, placebo-controlled study to evaluate the clinical efficacy and safety of an oral rehydration solution (Recuperat-ion®) in the treatment of fibromyalgia
| ISRCTN | ISRCTN91866393 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91866393 |
| Secondary identifying numbers | RE-FM-01-02 |
- Submission date
- 13/06/2007
- Registration date
- 26/06/2007
- Last edited
- 02/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jordi Carbonell
Scientific
Scientific
Hospital Del Mar
Sº Reumatologia
PG. MARITIM Nº 25-29
Barcelona
08003
Spain
Study information
| Study design | Multicentre, randomised, triple-blind, placebo controlled pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Multicentre, randomised, triple-blind, placebo-controlled study to evaluate the clinical efficacy and safety of an oral rehydration solution (Recuperat-ion®) in the treatment of fibromyalgia |
| Study objectives | Fibromyalgia (FM) is a complex, chronic condition which causes widespread pain and fatigue, as well as a variety of other symptoms that reflect an increased central hypersensitivity to pain and to multiple sensations. Despite the improved knowledge of FM, treatment is still palliative. There is evidence to support the use of antidepressants, cardiovascular exercise, cognitive behavioural therapy, patient education, or a combination of all of them. Complementary therapies are used very often, among them nutritional therapies (vitamins, ions, minerals, and others). Moreover, other treatments with ions and minerals are empirical and remain challenging. Because there is no currently no magic pill for FM, treatment aims at managing FM symptoms to the greatest extent possible. In order to improve their symptoms, especially pain and fatigue, the present study was undertaken to ascertain the influence of an oral beverage solution, Recuperat-ion®; which contains carbohydrates (glucose and fructose), and ions and minerals (sodium, potassium, calcium and magnesium) to improve pain and fatigue in FM patients. Calcium plays a role in mediating muscle contraction and nerve transmission. Magnesium is required for both anaerobic and aerobic energy generation and for glycolysis, either indirectly as a part of the Magnesium-Adenosine Triphosphate (Mg-ATP) complex or directly as an enzyme activator. Sodium aids in nerve impulse conduction and muscle contraction control. In addition to calcium, potassium is important in the regulation of neuromuscular activity. |
| Ethics approval(s) | This study was approved by the ethical committee of each one of the three hospitals: 1. Hospital del Mar: 17th July 2003 2. Hospital General Universitari Vall dHebron: 14th May 2003 3. Hospital Clínic i Provincial de Barcelona: 2nd April 2003 |
| Health condition(s) or problem(s) studied | Fibromyalgia |
| Intervention | Group one: Recuperat-ion® Group two: placebo A 15-day washout period was required (pre-treatment period). Response to therapy was evaluated at 30, 60, 90, 120, 150, and 180 days (treatment period), and a 30-day observation period followed (post-treatment period). All patients took four sachets (diluted in 300 ml of water or fruit juice) per day distributed over the four meals. Compliance with trial medication was monitored throughout the study. Laboratory tests were performed at baseline and at 90 and 180 days. The following was evaluated at the initial visit and at 30, 60, 90, 120, 150, and 180 days: 1. Severity of pain and fatigue (visual analogue pain rating scale) 2. Pain in tender points (digital palpation) 3. General health status and quality of life (Nottingham Health Profile) 4. Psychological well-being (Faces Scale, Hospital Anxiety and Depression Scale) A global assessment of treatment efficacy was made by the physician and the patient at the end of the treatment period. Comparisons between the two treatments were performed using intention-to-treat-and-cure statistical methods. All statistical procedures were conducted using SPSS statistical software v10.1. This study was approved by the ethics committees of the three hospitals. All patients gave their written informed consent. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Recuperat-ion® (oral rehydration solution) |
| Primary outcome measure | To ascertain the influence of an oral beverage solution (Recuperat-ion®) on pain, fatigue and mood in FM patients, measured at initial visit and at 30, 60, 90, 120, 150, and 180 days. |
| Secondary outcome measures | To evaluate: 1. General health status and quality of life (The Nottingham Health Profile), measured at initial visit and at 30, 60, 90, 120, 150, and 180 days 2. Psychological well-being (The Faces Scale, Hospital Anxiety and Depression Scale), measured at initial visit and at 30, 60, 90, 120, 150, and 180 days |
| Overall study start date | 07/01/2003 |
| Completion date | 04/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | A total of 72 patients were enrolled and evaluated and included in the analysis of efficacy and safety |
| Key inclusion criteria | 1. Male and female patients between 18 and 65 years old 2. Has FM according to official diagnostic criteria for FM established in 1990 by the American College of Rheumatology (ACR) 3. Duration of the illness of ten years or less |
| Key exclusion criteria | 1. History of renal failure (creatinine equal to or superior than 1.8 mL/dL), coronary disease in the last six months, angina, congestive heart disease, diabetes mellitus type one and two 2. Any life-threatening chronic disease (i.e., cancer disease, inflammatory bowel disease and active immune disorders) 3. Rheumatic disease (i.e., inflammatory arthritis, polymyositis, polymyalgia rheumatica) 4. Osteomalacia and osteoporosis 5. Metabolic and endocrine disease (i.e., hypothyroidism and hyperthyroidism, hyperparathyroidism, adrenal insufficiency, metabolic myopathy) 6. Infectious diseases (i.e., Epstein-Barr virus disease, brucellosis) 7. Rheumatic disease of soft tissue and myofascial pain syndrome 8. Parkinsons disease 9. Women to become pregnant or nursing 10. Patients who are enrolled in other clinical trial or patients who participated in other clinical trial in the last 30 days 11. Any psychological or psychiatric disease to compromise the understanding of the instructions giving by the investigator 12. Any subject to be unable to follow a good complementation of the treatment 13. Any patient who denies to give the informed consent to participate in this trial |
| Date of first enrolment | 07/01/2003 |
| Date of final enrolment | 04/09/2006 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hospital Del Mar
Barcelona
08003
Spain
08003
Spain
Sponsor information
Recuperat-ion Electrolitos, S.L. (Spain)
Industry
Industry
ARIBAU 198, 5.
Barcelona
08036
Spain
| Phone | +34 902 190 246 |
|---|---|
| info@recuperat-ion.com | |
| Website | http://www.recuperat-ion.com/ |
"ROR" |
https://ror.org/05pe6et34 |
Funders
Funder type
Industry
Recuperat-ion Electrolitos, S.L. (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Poster results | No | No |
Editorial Notes
02/10/2017: internal review.
