NCT01108549

Brief Summary

To determine whether adding Ribose 5 grams 3 x day would improve quality of life, energy, sleep and cognitive function and decrease pain in patients with CFS and/or fibromyalgia (CFS/FMS).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
257

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2010

Completed
Last Updated

April 22, 2010

Status Verified

April 1, 2010

Enrollment Period

5 months

First QC Date

April 16, 2010

Last Update Submit

April 20, 2010

Conditions

FibromyalgiaChronic Fatigue Syndrome

Keywords

FibromyalgiaChronic Fatigue SyndromeD-ribosefatigue

Outcome Measures

Primary Outcomes (1)

  • total score of hedonic scale of 5 symptoms

    The assessed symptoms were energy, sleep, cognitive function, pain(inverse score) and overall sense of well being. Patients were asked to rate each of the 5 symptoms on a 1 to 7 scale

    Change in total score of 5 symptoms after 3 weeks of treatment

Secondary Outcomes (3)

  • Total of change in hedonic scale

    at 1 week of treatment

  • total change in hedonic scale

    after 2 weeks of treatment

  • Side effects

    3 weeks

Interventions

RiboseDIETARY_SUPPLEMENT

Ribose 5 grams PO TID was taken daily

Also known as: D-ribose, corvalen

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with Fibromyalgia (FMS) (by American College of Rheumatology \[ACR\] criteria) and/or Chronic Fatigue Syndrome (CFS- by Centers for Disease Control \[CDC\] criteria) by a health practitioner.

You may not qualify if:

  • pregnant or nursing women, or
  • any participants with known severe medication or nutrient sensitivities, or
  • previous ribose use.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Enzymatic Therapy

Green Bay, Wisconsin, 54311, United States

Location

MeSH Terms

Conditions

FibromyalgiaFatigue Syndrome, ChronicFatigue

Interventions

Ribose

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesEncephalomyelitisNeuroinflammatory DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PentosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Jacob E Teitelbaum, MD

    Kona Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 16, 2010

First Posted

April 22, 2010

Study Start

April 1, 2009

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

April 22, 2010

Record last verified: 2010-04

Locations

US(1)