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

Hospital Del Mar
Sº Reumatologia
PG. MARITIM Nº 25-29
Barcelona
08003
Spain

Study information

Study designMulticentre, randomised, triple-blind, placebo controlled pilot study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleMulticentre, 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 objectivesFibromyalgia (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 d’Hebron: 14th May 2003
3. Hospital Clínic i Provincial de Barcelona: 2nd April 2003
Health condition(s) or problem(s) studiedFibromyalgia
InterventionGroup 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Recuperat-ion® (oral rehydration solution)
Primary outcome measureTo 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 measuresTo 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 date07/01/2003
Completion date04/09/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsA total of 72 patients were enrolled and evaluated and included in the analysis of efficacy and safety
Key inclusion criteria1. 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 criteria1. 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. Parkinson’s 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 enrolment07/01/2003
Date of final enrolment04/09/2006

Locations

Countries of recruitment

  • Spain

Study participating centre

Hospital Del Mar
Barcelona
08003
Spain

Sponsor information

Recuperat-ion Electrolitos, S.L. (Spain)
Industry

ARIBAU 198, 5.
Barcelona
08036
Spain

Phone +34 902 190 246
Email info@recuperat-ion.com
Website http://www.recuperat-ion.com/
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.