Arsenical MelanosisPhase 3SETACNCT01442727
Selenium in the Treatment of Arsenic Toxicity and Cancers
A Phase 3 study testing sodium selenite in people with Arsenical Melanosis and Arsenical Keratosis, run by Texas Tech University at 1 site in Bangladesh.
Trial summary
Context: Approximately 100 million people throughout the world consume water contaminated with arsenic at levels above carcinogenic thresholds, including 40 million in Bangladesh alone, with up to one-fourth of deaths attributed to arsenic exposure in the worst-affected regions. Read more about this study
- Who is it for?
- Ages 12 to 55 years
- Conditions the study is for
- Arsenical Melanosis, Arsenical Keratosis, Arsenical Cancers
- What is being tested?
- sodium selenite
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 819 participants
- Where
- 1 siteBangladesh
- Study dates
- Dec 2006to Apr 2009
- Phase
- Phase 3
- 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 12 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Resident of Bangladesh in an arsenic-affected region (Chandpur)
- Age between 12 and 55
- Exposure to arsenic in home drinking water greater than 50 ug/L.
- Arsenical melanosis on the torso confirmed by epiluminescence microscopy
Who cannot join
- Recent history or plans to consume selenium-containing supplements
- Anticipated change in home drinking water supply during study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Selenite in the Detoxification of Arsenic and the Prevention of Arsenical Melanosis and Cancers Amongst Bangladeshi Arsenicosis Patients: A 48-week, Randomized, Double-blinded, Placebo-controlled Phase III Trial
Context: Approximately 100 million people throughout the world consume water contaminated with arsenic at levels above carcinogenic thresholds, including 40 million in Bangladesh alone, with up to one-fourth of deaths attributed to arsenic exposure in the worst-affected regions. There are no proven therapies for treating chronic arsenic toxicity or for preventing arsenical cancers. Selenium has been known to counter arsenic toxicity in a variety of animal models. The investigators have recently shown in animals and humans that this effect is mediated by the formation of [(GS)2AsSe]- , the seleno-bis(S-glutathionyl) arsinium ion, which is then rapidly excreted via the hepatobiliary system. Concurrently, two Phase II studies in China and Bangladesh have suggested clinical benefit to selenium supplementation in arsenicosis patients.
Objective: To assess whether daily selenium supplementation counters arsenic toxicity in patients exposed to drinking water arsenic. If proven effective, selenium supplementation might be safely and cost-effectively implemented in the worst-affected localities.
- Conditions
- Arsenical Melanosis, Arsenical Keratosis, Arsenical Cancers, Arsenicosis, Arsenic Exposure, Arsenic Toxicity
- Being tested
- sodium selenite, placebo
- Keywords
- arsenical melanosis, arsenical melanoses, arsenical keratosis, arsenical keratoses, arsenical cancer, arsenic cancers, arsenic, arsenicosis, arsenic exposure, arsenic toxicity, arsenic poisoning, drinking water, selenium, selenite, sodium selenite
- Medical subject headings
- Arsenic Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sodium seleniteDrug
Also called selenium, selenite
200 micrograms (µg) of selenium in the form of sodium selenite; capsule form consumed once daily with breakfast.
placeboDrug
dicalcium phosphate capsule matching the selenium capsule in appearance; consumed once daily with breakfast
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients who receive control (placebo) Receives: Drug: placebo |
| Selenium | Active comparator | Patients who receive treatment (selenium) Receives: Drug: sodium selenite |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in arsenical melanosis
Arsenical melanosis was recorded in 4 quadrants of each patients' torsos using the Dermlite epiluminescence microscopy system. The images were then scored in a blinded, randomized fashion by a dermatologist.
Measured: 0 weeks (baseline), 24 weeks, and 48 weeks (end)
Secondary outcomes (2)
changes in blood arsenic levels
The levels of arsenic in patients' blood was measured to determine whether intervention had a differential effect.
Measured: week 0, week 24 and week 48
changes in urinary arsenic levels
The levels of arsenic in patients' urine was measured to determine whether intervention had a differential effect.
Measured: week 0, week 24 and week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startDec 2006
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arsenical MelanosisStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 819 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), American Cancer Society, Inc.
- Responsible party
- Principal investigator, Julian Spallholz, Texas Tech University
- Investigators
- Julian E Spallholz, PhD, Principal investigator, Texas Tech UniversityPaul F La Porte, PhD, Principal investigator, Pritzker School of Medicine, The University of ChicagoSelim Ahmed, MBBS, FCPS, Principal investigator, Institute of Child & Mother Health, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442727
- Sponsor's protocol ID
- TTU-JES-1
- Other IDs
- 1R21CA117111-01, ROG-06-098-01
- Acronym
- SETAC
- Status last verified
- Oct 2011
- First submitted
- 22 Sep 2011
- Last updated
- 7 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selenite in the Detoxification of Arsenic and the Prevention of Arsenical Melanosis and Cancers Amongst Bangladeshi Arsenicosis Patients: A 48-week, Randomized, Double-blinded, Placebo-controlled Phase III Trial
- ClinicalTrials.gov ID
- NCT01442727
- Acronym / sponsor ID
- SETAC / TTU-JES-1
- Conditions
- Arsenical Melanosis, Arsenical Keratosis, Arsenical Cancers, Arsenicosis, Arsenic Exposure, Arsenic Toxicity
- Keywords
- arsenical melanosis, arsenical melanoses, arsenical keratosis, arsenical keratoses, arsenical cancer, arsenic cancers, arsenic, arsenicosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 819 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), American Cancer Society, Inc.
- Study start
- Dec 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 28 Sep 2011 (estimated)
- 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.
Context: Approximately 100 million people throughout the world consume water contaminated with arsenic at levels above carcinogenic thresholds, including 40 million in Bangladesh alone, with up to one-fourth of deaths attributed to arsenic exposure in the worst-affected regions. There are no proven therapies for treating chronic arsenic toxicity or for preventing arsenical cancers. Selenium has been known to counter arsenic toxicity in a variety of animal models. The investigators have recently shown in animals and humans that this effect is mediated by the formation of [(GS)2AsSe]- , the seleno-bis(S-glutathionyl) arsinium ion, which is then rapidly excreted via the hepatobiliary system. Concurrently, two Phase II studies in China and Bangladesh have suggested clinical benefit to selenium supplementation in arsenicosis patients.
Objective: To assess whether daily selenium supplementation counters arsenic toxicity in patients exposed to drinking water arsenic. If proven effective, selenium supplementation might be safely and cost-effectively implemented in the worst-affected localities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: placeboPatients who receive control (placebo) |
| Selenium | Active comparator | Drug: sodium selenitePatients who receive treatment (selenium) |
Who may qualify
- Ages
- 12 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Resident of Bangladesh in an arsenic-affected region (Chandpur)
- Age between 12 and 55
- Exposure to arsenic in home drinking water greater than 50 ug/L.
- Arsenical melanosis on the torso confirmed by epiluminescence microscopy
Key exclusion criteria (2 listed)
- Recent history or plans to consume selenium-containing supplements
- Anticipated change in home drinking water supply during study period
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 |
|---|---|---|
| sodium seleniteAlso: selenium, selenite200 micrograms (µg) of selenium in the form of sodium selenite; capsule form consumed once daily with breakfast. | Drug | Selenium |
| placebodicalcium phosphate capsule matching the selenium capsule in appearance; consumed once daily with breakfast | Drug | Placebo |
Primary outcome
changes in arsenical melanosis
Time frame: 0 weeks (baseline), 24 weeks, and 48 weeks (end)
Arsenical melanosis was recorded in 4 quadrants of each patients' torsos using the Dermlite epiluminescence microscopy system. The images were then scored in a blinded, randomized fashion by a dermatologist.
2 secondary outcomes
changes in blood arsenic levels
Time frame: week 0, week 24 and week 48
changes in urinary arsenic levels
Time frame: week 0, week 24 and week 48
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 7 Oct 2011.
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.
Julian E Spallholz, PhD principal investigator
Texas Tech University
Paul F La Porte, PhD principal investigator
Pritzker School of Medicine, The University of Chicago
Selim Ahmed, MBBS, FCPS principal investigator
Institute of Child & Mother Health, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing sodium selenite in people with Arsenical Melanosis and Arsenical Keratosis, run by Texas Tech University at 1 site in Bangladesh.
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 4 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 7 Oct 2011. 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 Bangladesh. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
changes in arsenical melanosis (time frame: 0 weeks (baseline), 24 weeks, and 48 weeks (end)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2011.