Hydration in Children and Adolescents With Primary Headaches

NCT06816849 | Completed DMC

• 2 other identifiers: KME:0120-423/2023-2711-6Master Research
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

primary headache; pediatric; children; hydration; water intake

Outcome Measures

Primary Outcomes (3)

• Headache frequency

  Number of headache episodes over last three months.

  4 months

• Headache intensity

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

  4 months

• Headache duration

  Average length of headache episode measured in minutes.

  4 months

Secondary Outcomes (4)

• Change in total body water

  4 months

• Effect of nutritional advice on type of drink they have choosen

  4 months

• Change in extracellular water

  4 months

• Change in phase angle

  4 months

Study Arms (1)

Recommended fluid intake

EXPERIMENTAL

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

Interventions

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.

Recommended fluid intake

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Location

Related Publications (3)

• 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.

  PMID: 16128874 RESULT

• 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.

  PMID: 22113647 RESULT

• 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.

  PMID: 32446809 RESULT

MeSH Terms

Conditions

Cluster Headache

Condition Hierarchy (Ancestors)

Trigeminal Autonomic Cephalalgias; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 10, 2025
• Study Start: March 1, 2023
• Primary Completion: October 31, 2023
• Study Completion: June 30, 2024
• Last Updated: February 10, 2025

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)