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Hydration in Children and Adolescents With Primary Headaches

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06816849
Acronym
H20KIDS
Enrollment
60
Registered
2025-02-10
Start date
2023-03-01
Completion date
2024-06-30
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent, Children, Hydration, Primary Headaches (Includes Migraines, Tension, Cluster Headaches)

Keywords

primary headache, pediatric, children, hydration, water intake

Brief summary

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

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.

Interventions

OTHERRecommended 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.

Sponsors

University Medical Centre Ljubljana
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Headache frequency4 monthsNumber of headache episodes over last three months.
Headache intensity4 monthsHeadache severity measured with the Visual Analog Scale (0 - 10).
Headache duration4 monthsAverage length of headache episode measured in minutes.

Secondary

MeasureTime frameDescription
Change in total body water4 monthsChange in total body water (liter and %) assessed with bioelectrical impedance analysis (BIA 101 AKern) following the intervention.
Change in phase angle4 monthsChange in phase angle (°) assessed with bioelectrical impedance analysis (BIA 101 AKern) following the intervention.
Effect of nutritional advice on type of drink they have choosen4 monthsType of fluid they had increased during intervention.
Change in extracellular water4 monthsChange in extracellular water (liter and %) assessed with bioelectrical impedance analysis (BIA 101 AKern) following the intervention.

Countries

Slovenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026