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NCT01157208 · ClinicalTrials.gov registry record · NA
Nutrition for Chronic Daily Headache
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 67
- Enrollment target
NCT01157208 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 67 participants.
The verdict
NCT01157208, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 67 participants
- Enrollment target
Study Summary
The purpose of this study is: 1) To assess the feasibility of implementing a clinical trial comparing two potentially analgesic dietary interventions in patients with chronic daily headache (CDH) and 2)To assess the preliminary efficacy of the dietary interventions on headache frequency and severity and 3) to assess the impact of the diet on the percentage of omega-6 highly unsaturated fatty acids (HUFA) in total HUFA in whole blood. During a 6-week baseline phase, eligible individuals with CDH will complete web-based daily diaries, self-report questionnaires, and nutrient intake assessments. Before randomization to one of the two intervention groups, blood will be collected to measure baseline nutritional biomarkers. Targeted dietary advice will be administered and foods will be provided throughout the 12-week intervention phase. Samples for biomarkers will be collected every 4 weeks during the intervention. Participants will continue recording headache characteristics with a daily headache diary. At the conclusion of the intervention, participants will provide complete follow-up assessments and blood for nutritional biomarker measurement.
Interventions
- OTHER Diet A
- OTHER Diet B
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2009-07 |
| Est. Completion | 2011-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01157208
The ClinicalTrials.gov registry entry for NCT01157208 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Diet A is the first listed.
NCT01157208 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01157208 about?
NCT01157208 is a clinical study titled "Nutrition for Chronic Daily Headache". The purpose of this study is: 1) To assess the feasibility of implementing a clinical trial comparing two potentially analgesic dietary interventions in patients with chronic daily headache (CDH) and 2)To assess the preliminary efficacy of the dietary interventions on headache frequency and severity...
What is the current status of trial NCT01157208?
This trial is currently completed. It is a NA study. The enrollment target is 67 participants. The study started on 2009-07. Estimated completion is 2011-12.
What interventions are being tested in trial NCT01157208?
The interventions under investigation include: Diet A (OTHER), Diet B (OTHER).
Who is sponsoring clinical trial NCT01157208?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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