NCT00363506

Brief Summary

The purpose of this study is to evaluate the use of nutritional supplementation and dietary management for the reduction in frequency, duration, and intensity of migraine headache pain.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2006

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 24, 2008

Status Verified

April 1, 2008

First QC Date

August 9, 2006

Last Update Submit

April 22, 2008

Conditions

Migraine Disorders

Keywords

nutritionalC10.228.140.546.399.750

Outcome Measures

Primary Outcomes (1)

  • Migraine Impact and Disability Survey (MIDAS) - symptoms measured at study beginning and at 90 days

Interventions

Serotona Plus and dietary behavior managementBEHAVIORAL

Eligibility Criteria

Age18 Years - 72 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of migraines
  • Ages 18-72
  • Migraines more than once per month
  • Diagnosed migraines for more than one year

You may not qualify if:

  • Pregnant/nursing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide home based study program

Chesapeake, Virginia, 23320, United States

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • John J Carvalho, MBA

    Dynamic Health Resources

    STUDY CHAIR

Central Study Contacts

John J Carvalho, MBA

CONTACT

757-721-7781jjc@dynamichealthresources.com

Katherine huffman, MA

CONTACT

571-334-9154Katherine@dynamichealthresources.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 9, 2006

First Posted

August 15, 2006

Study Start

January 1, 2006

Study Completion

December 1, 2008

Last Updated

April 24, 2008

Record last verified: 2008-04

Locations

US(1)