A Randomized, Double-blind, Placebo-controlled, Comparative Clinical Trial to Measure the Maximun Heart Rate During a Cycle Ergometer Test After ReConnect® Supplementation in CFS.
Clinical Trial to Measure the Maximun HR After ReConnect ® Supplementation vs. Placebo in CFS.
Sponsors
Lead Sponsor
Collaborators
Source
Hospital Universitari Vall d'Hebron Research Institute
Oversight Info
Has Dmc
Yes
Brief Summary
The main objective is evaluate to safety and efficacy of oral Reconnect ® (food
supplementation composed by Coenzyme Q10, NADH, phosphoserine y vitamin C) on the maximum HR
during an exercise test in CFS
Detailed Description
Chronic Fatigue Syndrome (CFS) is a serious, complex and extremely debilitating chronic
illness, but often misunderstood characterized by prolonged fatigue, the hallmark of the
condition and multiple nonspecific symptoms. The World Health Organization has recognized CFS
as a disease that affecting the nervous system (ICD-10 G93.3) and multiple body systems. The
etiology is unknown. Previous studies have demonstrated in CFS patients a significant
reduction in plasma and intracellular Peripheral Blood Mononuclear Cells concentrations of
Coenzyme Q10 and NADH, which correlate with clinical symptoms of the disease. Hypothesis:
Supplementation with CoQ10 plus NADH could be beneficial in the improvement of clinical and
molecular parameters in this disease. The primary endpoint is to evaluate the efficacy of
oral Reconnect ® suplementation on the maximum heart rate changes during an exercise test in
CFS. The secondary endpoints are to evaluate the effect of Reconnect ® suplementation on
perception of fatigue (assessed by FIS), pain (McGill Pain Index Questionnaire), and sleep
disruption (Pittsburgh Sleep Index Questionnaire).
Patients and Methods: A total of 80 consecutive women patients with a diagnosis of CFS
according to the 1994 CDC Fukuda's definition criteria were initially evaluated and enrolled
in this study. The majority were excluded for no meet the inclusion criteria of the study.
All subjects are treatment with ReConnect® containing CoQ10 plus NADH versus placebo. Fatigue
levels, pain and sleep disturbances are scored using the Fatigue Impact Scale, McGill Pain
Questionnaire and Pittsburgh Sleep Quality Index, respectively.
Discussion: To our knowledge, no previous studies have yet evaluated the effectiveness of
oral ReConnect supplementation in CFS. ReConnect containing the combination of CoQ10 plus
NADH and other nutrients (phosphoserine and Vitamin C) can help to improve clinical symptoms
and restore mitochondrial function and oxidative stress reducing fatigue, pain and sleep
impairments in CFS. The combination of these supplements can result in a safe and effective
therapy to reduce fatigue, pain and improve sleep as well help restore quality of life of CFS
patients.
Overall Status
Completed
Start Date
2013-01-01
Completion Date
2013-12-01
Primary Completion Date
2013-01-01
Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Maximum HR changes after ReConnect supplementation during an incremental exercise test in CFS patients |
within the first 30 days (plus or minus 15 days) after treatment |
Secondary Outcome
Measure |
Time Frame |
|
Perception of fatigue, pain and sleep disruption after ReConnect supplementation during an incremental exercise test in CFS patients |
within the first 30 days (plus or minus 15 days) |
Enrollment
80
Condition
Intervention
Intervention Type
Dietary Supplement
Intervention Name
Description
ReConnect supplementation (NADH: 20 mg/day plus CoQ10: 200mg/day) divided into two daily dose ( 2 tablets/ before breakfast and 2 tablets/ before lunch)
Placebo supplementation divided into two daily dose ( 2 tablets/ before breakfast and 2 tablets/ before lunch)
Arm Group Label
ReConnect
Other Name
Placebo
Intervention Type
Dietary Supplement
Intervention Name
Description
placebo (phosphoserine/serine plus vitamin C) supplementation divided in two daily doses (2 tablets/before brekfast and 2 tablets/before lunch)
Arm Group Label
Placebo
Other Name
Placebo (phosphoserine/serine plus vitamin C)
Eligibility
Criteria
Inclusion Criteria:
- Patients female between 18 and 65 years old.
- CFS patients diagnosed with Chronic Fatigue Syndrome (CFS Clinical Unit, Vall d'Hebron
Hospital, Barcelona, Spain)
- Heart rate in radial pulse and seated between 50 to100 bpm, systolic BP between 100 to
140 mm Hg and diastolic BP between 50 to 90 mm Hg.
- Patients who give a written informed consent before initiating the study.
Exclusion Criteria:
- Patients for that is contraindicated or is not advisable to carry-out an ergometer
exercise test.
- Patients who are participating in another clinical trial of the same or differents
nature in the last 30 days prior to inclusion.
- Any participants who, in the opinion of the investigator, may not be able to follow
instructions or make a good treatment compliance.
- Subjects that do not give written informed consent to participate in the study.
- Participants who are receiving any drug or banned substances and is expected that
withdrawal of some medications/products not allowed in the study involves a
significants problem.
Gender
Female
Minimum Age
18 Years
Maximum Age
65 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Jose Alegre-Martin, MD, PhD |
Principal Investigator |
Vall d'Hebron University Hospital Research Institute. Internal Medicine Unit. |
Location
Facility |
|
Vall Hebron University Hospital Barcelona 08035 Spain |
Location Countries
Country
Spain
Verification Date
2015-02-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Vitamins
Ascorbic Acid
Coenzyme Q10
Arm Group
Arm Group Label
ReConnect
Arm Group Type
Active Comparator
Description
CFS patients who were randomized to measure the effect of oral ReConnect supplementation (NADH: 20 mg/day, Coenzyme Q10: 200 mg/day; 4 tablets/day) on the maximum HR during 8-weeks in term.
Arm Group Label
Placebo
Arm Group Type
Placebo Comparator
Description
CFS patients who were randomized to measure the effect of oral Placebo supplementation ( phosphoserine and vitamin C, 4 tablets/day) on the maximum HR during 8-weeks in term.
Firstreceived Results Date
N/A
Acronym
ReConnect
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)
Study First Submitted
February 5, 2014
Study First Submitted Qc
February 12, 2014
Study First Posted
February 14, 2014
Last Update Submitted
February 18, 2015
Last Update Submitted Qc
February 18, 2015
Last Update Posted
February 19, 2015
ClinicalTrials.gov processed this data on December 11, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.