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New ORS formula could protect diabetic pilgrims from heat stress

NCT ID NCT07618702

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a modified oral rehydration salts (ORS) drink designed for diabetic pilgrims at risk of heat stress and dehydration during the Hajj. The modified ORS has adjusted electrolytes and carbohydrates to avoid raising blood sugar. Researchers will compare it to standard ORS in 200 diabetic adults to see if it maintains hydration and electrolyte balance safely.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Modified oral rehydration salts (ORS) with adjusted electrolytes and carbohydrates
What this could lead to
If it works, this could provide a safer rehydration option for diabetic pilgrims during Hajj, reducing heat-related complications.
What could go wrong
This is a small, early-stage trial with 200 participants, so results may not apply to all diabetics. The modified ORS may not be as effective as standard ORS for hydration.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diabetic pilgrims attending Hajj. * Age between 18 and 80 years. * Willingness to participate and provide informed consent. * Diagnosis of Type 1 or Type 2 Diabetes Mellitus. Exclusion Criteria: * Patients with severe renal failure. * Patients with acute cardiovascular events. * Patients unable to take oral fluids. * Pregnancy or breastfeeding. * Participation in another clinical trial within the last 30 days.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

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Contacts and locations

Locations

  • Ministry of health

    Riyadh, Saudi Arabia

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