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Completed

NCT Number: NCT00181064

Atkins Diet for Difficult-to-Control Headaches in Teenagers

This is a 3-month pilot study of 10 adolescents with chronic daily headache. Teens will be placed on a modified Atkins diet and followed with 2 subsequent visits to assess for headache improvement.

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Key information

Conditions

Chronic Daily Headache Acid-Base Imbalance Acidosis Brain Diseases Central Nervous System Diseases Headache Headache Disorders Ketosis Metabolic Diseases Nervous System Diseases Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

About this study

Patients are placed on the diet and followed with various measures for 3 months. If the diet is helpful it is continued. Patients are still being enrolled as of 9/6/06.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages 12-19
  • Minimum 15 headaches/month for at least 3 months
  • Tried 2 preventative medications previously

Exclusion criteria

  • Prior use of the Atkins diet for more than 1 week
  • Pregnancy
  • Significant heart or kidney disease
  • Dangerously underweight
  • Using acute pain medications more than 11 days in the past month
  • Medications being changed

Treatment and study plan

Modified Atkins Diet

Behavioral

15 grams of carbohydrates per day - high fat diet

Primary outcomes

  1. Headaches

    Time frame: 3 months

Secondary outcomes

  1. Ketosis

    Time frame: 3 months

  2. Diet duration

    Time frame: as long as tolerated

  3. Quality of life (PedsMIDAS)

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

Use of the Atkins Diet for Adolescents With Chronic Daily Headache.

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 16, 2005
Registry last updated
Jul 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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