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Completed

NCT Number: NCT06816849

Hydration in Children and Adolescents With Primary Headaches

The aim of this study is to investigate the role of hydration and fluid intake in children and adolescents with primary headaches.

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Key information

Conditions

Primary Headaches (Includes Migraines, Tension, Cluster Headaches) Adolescent Brain Diseases Central Nervous System Diseases Children Cluster Headache Headache Disorders Headache Disorders, Primary Hydration Nervous System Diseases Trigeminal Autonomic Cephalalgias

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

About this study

Headches are one of the key factors affecting or even limiting the health and well-being of children and adolescents. Lifestyle recommendations could help reduce the risk of chronic headaches and improve overall well-being in this population. In clinical practice, adequate fluid intake is one of the general recommendations for headache management. However, scientific literature on the role of hydration and fluid intake in headaches is limited. To date, all studies have been conducted on adults, and no studies have examined this topic in the pediatric population.

As the first interventional study investigating the impact of adequate fluid intake on headaches in children and adolescents, our study will make a significant contribution to understanding the role of hydration in headache management and developing recommendations for improving headache control in the pediatric population.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 4-18 years.
  • Able to provide informed consent and willing to complete follow-up visits.
  • Primary headaches.
  • At least 1 headache per month.
  • Presence of headaches for at least 3 months or longer.

Exclusion criteria

  • Secondary headaches.
  • Without headaches for 3 months or more.

Treatment and study plan

Recommended water intake

Other

All participants received personalized consultation from a dietitian on adequate fluid intake and the selection of drinks based on dietary guidelines. They were required to follow the intervention for four months.

Primary outcomes

  1. Headache frequency

    Time frame: 4 months

    Number of headache episodes over last three months.

  2. Headache intensity

    Time frame: 4 months

    Headache severity measured with the Visual Analog Scale (0 - 10).

  3. Headache duration

    Time frame: 4 months

    Average length of headache episode measured in minutes.

Secondary outcomes

  1. Change in total body water

    Time frame: 4 months

    Change in total body water (liter and %) assessed with bioelectrical impedance analysis (BIA 101 AKern) following the intervention.

  2. Effect of nutritional advice on type of drink they have choosen

    Time frame: 4 months

    Type of fluid they had increased during intervention.

  3. Change in extracellular water

    Time frame: 4 months

    Change in extracellular water (liter and %) assessed with bioelectrical impedance analysis (BIA 101 AKern) following the intervention.

  4. Change in phase angle

    Time frame: 4 months

    Change in phase angle (°) assessed with bioelectrical impedance analysis (BIA 101 AKern) following the intervention.

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

The Role of Hydration in the Management of Pediatric Primary Headaches: A Pilot Study

Acronym: H20KIDS

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 10, 2025
Registry last updated
Feb 10, 2025

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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