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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: Completed NA study, sponsored by University of North Carolina, Chapel Hill.

NCT01157208 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 67 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Headache-related quality-of-life measure

Interventions

  • OTHER Diet A
  • OTHER Diet B

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 2009-07
Est. Completion 2011-12
Phase NA

What the finished NCT01157208 record still lists

NCT01157208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Diet A is the first listed.

NCT01157208 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01157208's enrollment target sits among peer trials

67 1139th of 2000 higher than 862 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01157208, the US trial registry maintained by the National Library of Medicine. NCT01157208 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.