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Study of Intravenous Sodium Thiosulfate for Treatment of Primary Raynaud's Phenomenon

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical study focuses on people with primary Raynaud's phenomenon, a condition where blood vessels in the fingers and toes narrow excessively in response to cold temperatures or stress, causing affected areas to turn white and blue and feel numb or painful. The study will test a medication called sodium thiosulfate, given through intravenous administration (directly into a vein) as a solution for infusion.

The purpose of this research is to determine how different doses of sodium thiosulfate affect blood vessel widening in people with Raynaud's phenomenon. During the study, participants will receive the medication through an infusion into their veins. The maximum daily dose will be 25 grams, and the treatment period will last for one day.

The study will measure how well blood flows through the small blood vessels in participants' hands using special imaging techniques. Researchers will also monitor the safety of the treatment by checking blood pressure, heart activity, and looking for any unwanted effects. Blood samples will be collected to understand how the medication moves through the body and affects various biological processes.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial preparation
You will need to stop taking all prescribed medications (except oral contraceptives) 14 days before each visit to the research center
48 hours before each visit, you must avoid consuming caffeine-containing products (coffee, tea, cola, chocolate, energy drinks), grapefruit or grapefruit juice, and alcohol
Step 2
Treatment administration
You will receive sodium thiosulfate through an intravenous infusion (delivered directly into your vein)
The medication will be administered in increasing doses over multiple sessions
The solution used will be Natriumthiosulfat 25% (solution for infusion)
Step 3
Monitoring during treatment
Your blood pressure will be continuously monitored
The injection site will be checked for any local reactions
An ECG (heart rhythm test) will be performed to monitor your heart activity
Blood samples will be collected to measure medication levels in your body
Step 4
Assessment procedures
Your hand will undergo cooling and rewarming tests while blood flow is measured using special equipment
Thermal images of your hand will be taken to assess blood circulation
Blood samples will be analyzed for various markers related to inflammation and oxidative stress
Step 5
Study duration
The study is scheduled to run from September 2025 to June 2026
Multiple visits to the research center will be required during this period

Who can join the trial?

11 criteria

Age between 18 and 45 years
Both females and males can participate
Must have been diagnosed with primary Raynaud's phenomenon
Must be a non-smoker or have quit smoking at least 3 months ago
Must have normal kidney function with an estimated glomerular filtration rate (eGFR) of 90 mL/min or higher (this measures how well your kidneys are filtering blood)
Must have a normal heart rhythm on ECG (heart electrical activity test) at screening
Must stop all prescribed medications (except birth control pills) at least 14 days before each study visit
Must avoid caffeine-containing products (coffee, tea, cola, chocolate, energy drinks) and grapefruit/grapefruit juice for 48 hours before each study visit
Must avoid alcohol for 48 hours before screening and each study visit
Must be willing to follow all study procedures and restrictions
Must understand the study procedures and provide written informed consent

Who cannot join the trial?

15 criteria

Age below 18 years or above 65 years
History of cardiovascular disease (heart and blood vessel problems)
Pregnant or breastfeeding women
Current use of medications that affect blood vessel function
Severe hypertension (high blood pressure)
History of allergic reactions to similar medications
Active infections or fever
Participation in other clinical trials within the past 30 days
Significant kidney or liver problems
Inability to follow study procedures
History of blood clotting disorders
Severe mental health conditions that could affect consent
Substance abuse within the past year
Uncontrolled diabetes mellitus (high blood sugar)
Recent surgery (within the past 3 months)

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Verified sites

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Universitair Medisch Centrum Groningen
Groningen, The Netherlands

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Investigated drugs

Sodium thiosulfate (STS) is a medication given through an intravenous (IV) line directly into the bloodstream. It acts as a vasodilator, which means it helps blood vessels expand and improve blood flow. In this trial, it is being studied for its potential to help people with Raynaud's phenomenon, a condition where small blood vessels in the fingers and toes narrow excessively in response to cold or stress, causing reduced blood flow to these areas.

Sodium Thiosulfate Pentahydrate

What is already known about the treatment

Sodium Thiosulfate - An inorganic compound administered intravenously that is being investigated for its potential therapeutic effects in treating Raynaud's phenomenon, a condition characterized by reduced blood flow to fingers and toes. This medication acts as a vasodilator, meaning it helps blood vessels expand, potentially improving circulation in affected areas. Currently undergoing clinical trials to evaluate its effectiveness and safety, sodium thiosulfate belongs to the class of inorganic sulfur compounds and has been previously used in medical practice for treating cyanide poisoning and reducing side effects of cisplatin chemotherapy.

Investigated diseases

Raynaud's phenomenon - A circulatory condition that causes blood vessels in the fingers and toes to narrow in response to cold temperatures or stress. During an episode, affected areas typically turn white, then blue due to lack of oxygen, and finally red as blood flow returns. The condition occurs when small blood vessels in the extremities overreact to temperature changes or emotional triggers. Episodes can last from minutes to hours and may cause tingling, numbness, and a cold sensation in the affected areas. Raynaud's phenomenon can occur on its own (primary) or as a result of another underlying condition (secondary).