Coenzyme Q10 Plus NADH Supplementation in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis

NCT03186027 | Completed

• 1 other identifier: VITAE 2015
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of the study is to examine the effect of oral CoQ10 plus NADH (Reconnect®) supplementation twice daily for 8-weeks on the changes in fatigue perception, sleep disturbances, autonomic dysfunction and HRQoL assessed by patient-reported outcome measures in CFS/ME.

Conditions

Chronic Fatigue Syndrome

Keywords

chronic fatigue; Sleep problems; Autonomic dysfunction; Health-Related Quality of Life; Coenzyme Q10; NADH

Outcome Measures

Primary Outcomes (1)

• Effect of oral Reconnect ® (CoQ10 plus NADH) supplementation on the changes in core symptoms during 8-weeks in CFS/ME subjects.

  Evaluate the effect of oral Reconnect ® supplementation on the changes in fatigue perception measured by the Fatigue Index Scale-40 (40 items) in all study participants. Items Rate: 0 (no fatigue) to 4 (severe fatigue).

  At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)

Secondary Outcomes (10)

• Demographic data and clinical parameters

  At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)

• Age of onset of symptoms

  At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)

• Concomitant conditions

  At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)

• Height will be measured and reported

  At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)

• Weight will be measured and reported

  At the beginning (session 2, week 1), intermedium stage (session 3, week 4) and at the close-up of study (session 4, week 8)

Study Arms (2)

Active supplement (CoQ10 plus NADH)

ACTIVE COMPARATOR

CFS/ME patients will be randomized to evaluate the effect of oral ReConnect supplementation (CoQ10: 200 mg/day plus NADH: 20 mg/day) taking 4 tablets/day during 8-weeks in term. Active supplement based on Coenzyme Q10 plus NADH

Dietary Supplement: Coenzyme Q10 plus NADH

Phosphoserine plus vitamin C

PLACEBO COMPARATOR

CFS/ME patients will be randomized to assess the effect of placebo (phospho-serine plus vitamin C) taking 4 tablets/day for 8-weeks in term. Placebo: phosphoserine plus vitamin C

Dietary Supplement: phosphoserine plus vitamin C

Interventions

Coenzyme Q10 plus NADH DIETARY_SUPPLEMENT

Active arm: Coenzyme Q10 plus NADH CFS/ME patients who will be randomized to measure the effect of oral ReConnect supplementation (CoQ10: 200 mg/day plus NADH 20 mg/day; 4 tablets/day) on changes in the fatigue, sleep problems, autonomic function and HRQoL during 8-weeks in term. Intervention: Reconnect

Active supplement (CoQ10 plus NADH)

phosphoserine plus vitamin C DIETARY_SUPPLEMENT

Placebo arm: phosphoserine plus vitamin C CFS/ME patients who will be randomized to measure the effect of oral Placebo supplementation (phosphoserine and vit C, 4 tablets/day) on changes in the fatigue, sleep problems, autonomic function and HRQoL during 8-weeks in term. Intervention: placebo

Phosphoserine plus vitamin C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients female between 18 and 65 years old.
• Body Mass Index (BMI) ≤ 30 mg/m²
• Subjects who met the 1994 Centers for Disease Control and Prevention/Fukuda definition and 2003 Canadian diagnostic criteria for CFS/ME.
• Patients must be able to participate, understand and complete questionnaires in Spanish language.
• Patients who give a signed informed consent before initiating the study.

You may not qualify if:

• Patients who do not fulfilled the 1994 Centers for Disease Control and Prevention/Fukuda definition and 2003 Canadian criteria for CFS/ME.
• Any participants who, in the opinion of the principal investigator, may not be able to follow instructions or make a good treatment compliance.
• Subjects that don't give signed 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 significant problem.
• Participants who are pregnant and/or breastfeeding,
• Participants with autoimmune disorder, cancer, endocrine and metabolic disorders, rheumatic conditions, multiple sclerosis, psychosis, major depression, cardiovascular disease, hematological conditions, use of oral anticoagulants, smokers or had a history of substance abuse.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead
• Vitae Health Innovation: collaborator

Study Sites (1)

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

Related Publications (6)

• Alegre J, Roses JM, Javierre C, Ruiz-Baques A, Segundo MJ, de Sevilla TF. [Nicotinamide adenine dinucleotide (NADH) in patients with chronic fatigue syndrome]. Rev Clin Esp. 2010 Jun;210(6):284-8. doi: 10.1016/j.rce.2009.09.015. Epub 2010 May 5. Spanish.

  PMID: 20447621 RESULT

• Castro-Marrero J, Cordero MD, Segundo MJ, Saez-Francas N, Calvo N, Roman-Malo L, Aliste L, Fernandez de Sevilla T, Alegre J. Does oral coenzyme Q10 plus NADH supplementation improve fatigue and biochemical parameters in chronic fatigue syndrome? Antioxid Redox Signal. 2015 Mar 10;22(8):679-85. doi: 10.1089/ars.2014.6181. Epub 2014 Dec 18.

  PMID: 25386668 RESULT

• Castro-Marrero J, Saez-Francas N, Segundo MJ, Calvo N, Faro M, Aliste L, Fernandez de Sevilla T, Alegre J. Effect of coenzyme Q10 plus nicotinamide adenine dinucleotide supplementation on maximum heart rate after exercise testing in chronic fatigue syndrome - A randomized, controlled, double-blind trial. Clin Nutr. 2016 Aug;35(4):826-34. doi: 10.1016/j.clnu.2015.07.010. Epub 2015 Jul 17.

  PMID: 26212172 RESULT

• Castro-Marrero J, Saez-Francas N, Santillo D, Alegre J. Treatment and management of chronic fatigue syndrome/myalgic encephalomyelitis: all roads lead to Rome. Br J Pharmacol. 2017 Mar;174(5):345-369. doi: 10.1111/bph.13702. Epub 2017 Feb 1.

  PMID: 28052319 RESULT

• Curriu M, Carrillo J, Massanella M, Rigau J, Alegre J, Puig J, Garcia-Quintana AM, Castro-Marrero J, Negredo E, Clotet B, Cabrera C, Blanco J. Screening NK-, B- and T-cell phenotype and function in patients suffering from Chronic Fatigue Syndrome. J Transl Med. 2013 Mar 20;11:68. doi: 10.1186/1479-5876-11-68.

  PMID: 23514202 RESULT

• Castro-Marrero J, Cordero MD, Saez-Francas N, Jimenez-Gutierrez C, Aguilar-Montilla FJ, Aliste L, Alegre-Martin J. Could mitochondrial dysfunction be a differentiating marker between chronic fatigue syndrome and fibromyalgia? Antioxid Redox Signal. 2013 Nov 20;19(15):1855-60. doi: 10.1089/ars.2013.5346. Epub 2013 May 29.

  PMID: 23600892 RESULT

Related Links

• Vall d'Hebron University Hospital Research Institute (VHIR)
• Vall d'Hebron University Hospital (HUVH)

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Parasomnias; Primary Dysautonomias

Interventions

coenzyme Q10; NAD; Phosphoserine; Ascorbic Acid

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Mental Disorders; Autonomic Nervous System Diseases

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins; Phosphoamino Acids; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Jose Alegre, MD; PhD

  Vall d'Hebron University Hospital (CFS/ME Clinical Unit)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The investigator, care provider and participants do not know which individuals have been assigned in each arm or comparison group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Active Dietary Supplement: ReConnect (CoQ10 plus NADH) and excipients. ReConnect supplementation (CoQ10: 200mg/day plus NADH 20 mg/day) divided into 2 daily dose (2 tablets/ before breakfast and 2 tablets/ before lunch). Excipient Dietary Supplement: Placebo (serine plus vitamin C) Placebo supplementation divided into two daily dose (2 tablets/before breakfast and 2 tablets/ before lunch)

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: June 14, 2017
• Study Start: June 28, 2017
• Primary Completion: May 28, 2020
• Study Completion: September 1, 2021
• Last Updated: September 21, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)