Hydration in Children and Adolescents With Primary Headaches (H20KIDS)

February 3, 2025 updated by: University Medical Centre Ljubljana

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Medical Centre Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Recommended fluid intake
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.
Other: Recommended water intake
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Headache frequency
Time Frame: 4 months
Number of headache episodes over last three months.
4 months
Headache intensity
Time Frame: 4 months
Headache severity measured with the Visual Analog Scale (0 - 10).
4 months
Headache duration
Time Frame: 4 months
Average length of headache episode measured in minutes.
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months
Effect of nutritional advice on type of drink they have choosen
Time Frame: 4 months
Type of fluid they had increased during intervention.
4 months
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 months
Change in phase angle
Time Frame: 4 months
Change in phase angle (°) assessed with bioelectrical impedance analysis (BIA 101 AKern) following the intervention.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

January 27, 2025

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KME:0120-423/2023-2711-6
  • Master Research (Other Identifier: University Medical Centre Ljubljana and University of Ljubljana, Slovenia)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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