Drinking Extra Water for to Prevent or Decrease Headaches

Headache Clinical Trial

Official title:

Drinking Extra Water To Prevent or Decrease Headaches - A Feasibility Online Randomized Controlled Trial With Adult Participants

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02330809
• Other study ID #: ThinkWell-PLOT-01
• Status: Withdrawn
• Phase: N/A
• Start date: February 2019
• Est. completion date: November 2019

Study information

• Verified date: March 2021
• Source: ThinkWell
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out if drinking extra water helps people prevent or relieve headaches and hunger and, if so, what volume of water is most effective and when is it best to drink it?

Description:

If participants decide to participate in this trial, they will be asked to drink a specific amount of water at particular times of the day for 14 days. A computer will decide by chance the amount of water they will be asked to drink each day of the trial and the times at which to drink this.

There are different amounts and different times that people will be asked to drink water, this is so that the investigators can find out if there is an optimal volume of water to drink, and a best time to drink water to reduce headaches or hunger. The least amount of water the computer could ask participants to drink is half a glass (that is 4oz or 120ml). The largest volume of water the computer could ask participants to drink would be eight glasses of water a day (a total of 64oz or 2L) spread across the day (that is not all at once). Once the computer has assigned participants to a particular volume and times to drink water, these will remain the same for every day throughout the study.

Participants will be asked to provide some brief information about themselves at the beginning of the study (for example, age, sex, height and whether you exercise, smoke or not). During the study they will be asked to weigh themselves and record this, Their dietary habits and the amount they drink will be kept on a private and confidential page on the study website. They will be asked to fill in [2] confidential short surveys about how they feel and their views, one at the start and one at the end of the study.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Any adult (defined as someone aged 18 or above) for whom advice to drink extra water is not contraindicated.

Exclusion Criteria

General exclusions

• < 18 years of age

• No personal email address

• Pregnancy

• Ecstasy recreational drug use

Exclusions Health Conditions

• Impaired renal function

• Chronic bowel problems

• Low sodium levels

• Diabetes insipidus

• Schizophrenia or history of psychosis

• Anorexia or bulimia

• Congestive heart failure

• Current chemotherapy treatment

Exclusions Concurrent Medications

• Taking regular non-steroidal anti-inflammatory drugs

• Diuretics (e.g. thiazides, indapamide, loop diuretics), also called "water tablets"

• Anti-depressants: Selective serotonin re-uptake inhibitors (SSRIs), Tricyclic and tetracyclic antidepressants (TCAs),monoamine oxidase inhibitor (MAOIs)

• Anti-psychotics (e.g. haloperidol)

• Anti-convulsants (e.g. sodium valproate, carbamazepine)

• Cancer drugs (anti-neoplastic agents)

Implicit exclusions

• People without internet access

• People who cannot read

• People without the ability to understand the website and informed consent documents

Related Conditions & MeSH terms

• Headache

Intervention

Other:
• Daily extra water intake
Amount of extra daily water intake to consume
• Timing of daily extra water intake
Intervention-A: Timing of daily extra water intake specified Intervention-B: at any time during 24 hour period

Locations

Country	Name	City	State
United Kingdom	ThinkWell	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
ThinkWell

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of headache frequency/intensity	Online participant reported visual analog scales	Daily for 14 days
Secondary	Hunger	Online participant reported Visual analog scales	Daily for 14 days
Secondary	Mood Questionnaire	Mood will be measured online using happy, sad, neutral faces	Daily for 14 days
Secondary	Body mass index (BMI)	Participants will use an automated online BMI calculator	Baseline and day 14
Secondary	Wellbeing	Patient Reported Outcome Measurement Information System (PROMIS) will be used to measure patient-reported outcome (PRO) for answers that patients provide to questions to produce numeric values which indicate patients' state of wellbeing or suffering as well as their ability or lack of ability to function.	Baseline and day 14