Hydration in Children and Adolescents With Primary Headaches

NCT ID: NCT06816849

Last Updated: 2025-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Recommended water intake

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Medical Centre Ljubljana

Ljubljana, , Slovenia

Site Status

Countries

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Slovenia

References

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Spigt MG, Kuijper EC, Schayck CP, Troost J, Knipschild PG, Linssen VM, Knottnerus JA. Increasing the daily water intake for the prophylactic treatment of headache: a pilot trial. Eur J Neurol. 2005 Sep;12(9):715-8. doi: 10.1111/j.1468-1331.2005.01081.x.

Reference Type RESULT
PMID: 16128874 (View on PubMed)

Spigt M, Weerkamp N, Troost J, van Schayck CP, Knottnerus JA. A randomized trial on the effects of regular water intake in patients with recurrent headaches. Fam Pract. 2012 Aug;29(4):370-5. doi: 10.1093/fampra/cmr112. Epub 2011 Nov 23.

Reference Type RESULT
PMID: 22113647 (View on PubMed)

Khorsha F, Mirzababaei A, Togha M, Mirzaei K. Association of drinking water and migraine headache severity. J Clin Neurosci. 2020 Jul;77:81-84. doi: 10.1016/j.jocn.2020.05.034. Epub 2020 May 20.

Reference Type RESULT
PMID: 32446809 (View on PubMed)

Other Identifiers

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Master Research

Identifier Type: OTHER

Identifier Source: secondary_id

KME:0120-423/2023-2711-6

Identifier Type: -

Identifier Source: org_study_id

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