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

2 1 1 1

What is this study about?

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.

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

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)

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

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

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 Study?

  • 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 Study?

  • 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)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Uuxtcfqlzliz Mzdrhqm Cvfukdp Gdwarvnph Groningen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
01.09.2025

Trial locations

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.

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).

Trial ID:
2023-509432-25-00
Protocol code:
STS-001
Trial Phase:
Therapeutic exploratory (Phase II)

Other Trials to Consider

  • Study on Clopidogrel’s Effect in Preventing Systemic Sclerosis for Patients with Raynaud’s Phenomenon and Specific Immune Conditions

    Recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    France