Cyclic Vomiting SyndromeNCT00728104
The Use of L-Carnitine And CoQ10 Supplements In the Treatment of Cyclic Vomiting Syndrome (CVS)
An observational study of Cyclic Vomiting Syndrome, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
This is a study with the principle goal being to learn about the use of L-Carnitine and CoQ10, two vitamin supplements that are currently being used to treat Cyclic Vomiting Syndrome, largely initiated by parents. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cyclic Vomiting Syndrome
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Cyclic Vomiting Syndrome (CVS) is a condition where children and adults have repeated attacks of severe vomiting, nausea, abdominal pain, headaches, and tiredness. These episodes can last from several hours to several days.
Who may be able to join
- 3 discrete episodes of vomiting
- normal health between episodes
- stereotypical clinical pattern
- no abnormal test results to account for vomiting (see exclusion criteria)
Who cannot join
- abnormal UGI with small bowel follow-through revealing an anatomic anomaly, inflammatory or obstructive
- Significantly abnormal endoscopic biopsies (moderate to severe esophagitis, H. pylori)
- Abnormal abdominal ultrasound revealing hydronephrosis, cholelithiasis, pancreatitis
- Positive screening for endocrine disorder (diabetic ketoacidosis, Addison's)
- Positive screening for inborn errors of metabolism (hypoglycemia, lactic acidosis, hyperammonemia, organic acidemia, amino aciduria, elevated beta-ALA, porphobilinogen)
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: Co-Enzyme Q10, L-Carnitine and Amitriptyline Usage in Cyclic Vomiting Syndrome (CVS): A Research Study
This is a study with the principle goal being to learn about the use of L-Carnitine and CoQ10, two vitamin supplements that are currently being used to treat Cyclic Vomiting Syndrome, largely initiated by parents. We want to learn how effective these supplements are compared to standard treatment, at what dose, and what onset of action in order to initiate future prospective study on these supplements.
- Conditions
- Cyclic Vomiting Syndrome
- Keywords
- Learn, L-Carnitine, Co-enzyme Q10, Effective, These supplements, Compared, Standard
- Medical subject headings
- Familial cyclic vomiting syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | The General Questionnaire: help to understand which characteristics of CVS patients are associated with both beneficial and harmful effects of these treatments | |
| 2 | The Co-Enzyme Q10 Questionnaire: to be completed by individuals who ever taken co-enzyme Q10 | |
| 3 | The L-Carnitine Questionnaire: to be completed by individuals who have ever taken L-carnitine | |
| 4 | The Amitriptyline Questionnaire: to be completed by individuals who have ever taken amitriptyline |
What is being measured
The primary outcome is the main question the study is designed to answer.
How two vitamin supplements are being used to treat cyclic vomiting syndrome
Measured: Two years
Secondary outcomes (1)
How effective these supplements appear to be compared to standard treatment
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study startOct 2007
- Primary completionJan 2017 (estimated)
- Study completionJan 2017 (estimated)
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cyclic Vomiting SyndromeStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Los Angeles
- Responsible party
- Principal investigator, B Li, Medical College of Wisconsin
- Investigators
- B Li, MD, Principal investigator, Medical College of Wiconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728104
- Sponsor's protocol ID
- 090
- Status last verified
- Feb 2017
- First submitted
- 31 Jul 2008
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-Enzyme Q10, L-Carnitine and Amitriptyline Usage in Cyclic Vomiting Syndrome (CVS): A Research Study
- ClinicalTrials.gov ID
- NCT00728104
- Acronym / sponsor ID
- 090
- Conditions
- Cyclic Vomiting Syndrome
- Keywords
- Learn, L-Carnitine, Co-enzyme Q10, Effective, These supplements, Compared, Standard
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Children's Hospital Los Angeles
- Study start
- Oct 2007
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 5 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study with the principle goal being to learn about the use of L-Carnitine and CoQ10, two vitamin supplements that are currently being used to treat Cyclic Vomiting Syndrome, largely initiated by parents. We want to learn how effective these supplements are compared to standard treatment, at what dose, and what onset of action in order to initiate future prospective study on these supplements.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –The General Questionnaire: help to understand which characteristics of CVS patients are associated with both beneficial and harmful effects of these treatments |
| 2 | – | –The Co-Enzyme Q10 Questionnaire: to be completed by individuals who ever taken co-enzyme Q10 |
| 3 | – | –The L-Carnitine Questionnaire: to be completed by individuals who have ever taken L-carnitine |
| 4 | – | –The Amitriptyline Questionnaire: to be completed by individuals who have ever taken amitriptyline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cyclic Vomiting Syndrome (CVS) is a condition where children and adults have repeated attacks of severe vomiting, nausea, abdominal pain, headaches, and tiredness. These episodes can last from several hours to several days.
Key inclusion criteria (4 listed)
- 3 discrete episodes of vomiting
- normal health between episodes
- stereotypical clinical pattern
- no abnormal test results to account for vomiting (see exclusion criteria)
Key exclusion criteria (5 listed)
- abnormal UGI with small bowel follow-through revealing an anatomic anomaly, inflammatory or obstructive
- Significantly abnormal endoscopic biopsies (moderate to severe esophagitis, H. pylori)
- Abnormal abdominal ultrasound revealing hydronephrosis, cholelithiasis, pancreatitis
- Positive screening for endocrine disorder (diabetic ketoacidosis, Addison's)
- Positive screening for inborn errors of metabolism (hypoglycemia, lactic acidosis, hyperammonemia, organic acidemia, amino aciduria, elevated beta-ALA, porphobilinogen)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
How two vitamin supplements are being used to treat cyclic vomiting syndrome
Time frame: Two years
1 secondary outcome
How effective these supplements appear to be compared to standard treatment
Time frame: Two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Cyclic Vomiting Syndrome AssociationLink provided by the sponsor.
Related trials for Cyclic Vomiting Syndrome
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A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome
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Autonomic Reactivity and Personalized Neurostimulation
Functional Gastrointestinal Disorders (FGIDs), Cyclic Vomiting Syndrome
RecruitingObservational study
Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.
Functional Gastrointestinal Disorders, Gastroesophageal Reflux
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
B Li, MD principal investigator
Medical College of Wiconsin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cyclic Vomiting Syndrome, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
How two vitamin supplements are being used to treat cyclic vomiting syndrome (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2017.