Primary Headaches (Includes Migraines, Tension, Cluster Headaches)H20KIDSNCT06816849
Hydration in Children and Adolescents With Primary Headaches
A study testing Recommended water intake in people with Primary Headaches (Includes Migraines, Tension, Cluster Headaches) and Hydration, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The aim of this study is to investigate the role of hydration and fluid intake in children and adolescents with primary headaches. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Primary Headaches (Includes Migraines, Tension, Cluster Headaches), Hydration, Adolescent
- What is being tested?
- Recommended water intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Mar 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Secondary headaches.
- Without headaches for 3 months or more.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Headaches (Includes Migraines, Tension, Cluster Headaches), Hydration, Adolescent, Children
- Being tested
- Recommended water intake
- Keywords
- primary headache, pediatric, children, hydration, water intake
- Medical subject headings
- Cluster Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recommended water intakeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Recommended water intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache frequency
Number of headache episodes over last three months.
Measured: 4 months
Headache intensity
Headache severity measured with the Visual Analog Scale (0 - 10).
Measured: 4 months
Headache duration
Average length of headache episode measured in minutes.
Measured: 4 months
Secondary outcomes (4)
Change in total body water
Change in total body water (liter and %) assessed with bioelectrical impedance analysis (BIA 101 AKern) following the intervention.
Measured: 4 months
Effect of nutritional advice on type of drink they have choosen
Type of fluid they had increased during intervention.
Measured: 4 months
Change in extracellular water
Change in extracellular water (liter and %) assessed with bioelectrical impedance analysis (BIA 101 AKern) following the intervention.
Measured: 4 months
Change in phase angle
Change in phase angle (°) assessed with bioelectrical impedance analysis (BIA 101 AKern) following the intervention.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start1 Mar 2023
- Primary completion31 Oct 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary Headaches (Includes Migraines, Tension, Cluster Headaches)Studies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816849
- Sponsor's protocol ID
- KME:0120-423/2023-2711-6
- Other IDs
- Master Research
- Acronym
- H20KIDS
- Status last verified
- Mar 2023
- First submitted
- 27 Jan 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16128874Spigt 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.
PubMed 22113647Khorsha 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.
PubMed 32446809
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Hydration in the Management of Pediatric Primary Headaches: A Pilot Study
- ClinicalTrials.gov ID
- NCT06816849
- Acronym / sponsor ID
- H20KIDS / KME:0120-423/2023-2711-6
- Conditions
- Primary Headaches (Includes Migraines, Tension, Cluster Headaches), Hydration, Adolescent, Children
- Keywords
- primary headache, pediatric, children, hydration, water intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 10 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recommended fluid intake | Experimental | Other: Recommended water intakeAll 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. |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Secondary headaches.
- Without headaches for 3 months or more.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recommended water intakeAll 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 fluid intake |
Primary outcome
Headache frequency
Time frame: 4 months
Number of headache episodes over last three months.
Headache intensity
Time frame: 4 months
Headache severity measured with the Visual Analog Scale (0 - 10).
Headache duration
Time frame: 4 months
Average length of headache episode measured in minutes.
4 secondary outcomes
Change in total body water
Time frame: 4 months
Effect of nutritional advice on type of drink they have choosen
Time frame: 4 months
Change in extracellular water
Time frame: 4 months
Change in phase angle
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Results publication: PubMed 16128874Spigt 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.
- Results publication: PubMed 22113647Spigt 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.
- Results publication: PubMed 32446809Khorsha 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recommended water intake in people with Primary Headaches (Includes Migraines, Tension, Cluster Headaches) and Hydration, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache frequency (time frame: 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06816849, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.