ToxicityPhase 2ALANCT02760823
Alpha Lipoic Acid as an Adjuvant Treatment in Acute Phosphide Poisoning
A Phase 2 study testing Alpha Lipoic Acid (Thioctacid) in people with Toxicity, run by Heba Allah Ali Abd El-Halim Mabrouk.
Trial summary
The aim of this study is to evaluate efficacy and safety of Alpha Lipoic Acid(ALA) as an adjuvant in the management of patients with acute phosphide poisoning. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Toxicity
- What is being tested?
- Alpha Lipoic Acid (Thioctacid)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jan 2018
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients (male or female, aged 12 years or older) with symptomatic acute phosphide poisoning (deliberate or accidental), with diagnosis made on the basis of:
- The typical clinical manifestations due to and following shortly after a single exposure to phosphide.
- Reliable identification of the compound based on the container brought by patient attendants or a subsequent confirmation by silver nitrate test for phosphine detection in stomach contents.
Who cannot join
- Patients less than 12 years of age
- Pregnant and lactating women
- Patients with ingestion or exposure to other substances in addition to phosphide.
- Patients with other major medical conditions (e.g. cardiovascular disease, renal or hepatic failure).
- Patients presenting more than 6 hours of having consumed the phosphide compound (late presenters).
- Patients treated for acute phosphide poisoning in any medical center before admission.
About this study
Official title: Alpha Lipoic Acid as an Adjuvant Treatment in Acute Phosphide Poisoning: A Randomized Clinical Trial
The aim of this study is to evaluate efficacy and safety of Alpha Lipoic Acid(ALA) as an adjuvant in the management of patients with acute phosphide poisoning.
Read the detailed description
The study will be carried out following approval of the research ethical committee of Tanta Faculty of Medicine on patients admitted to The Poison Control Unit (Emergency Hospital, Tanta University and Emergency Hospital, Mansoura University) with acute phosphide poisoning in the period from January 2016 to January 2018. A written informed consent will be taken from each patient or his/her guardians (if the patient was unable to participate in the consent process). Confidentiality of the data will be maintained by making code numbers for each patient. The investigators plan to conduct a randomized clinical trial to evaluate efficacy and safety of ALA as an adjuvant in treatment of patients with acute phosphide poisoning. Fifty patients will be randomized to ALA or a non ALA in a 1:1 ratio (25 patients in each group). ALA will be given IV, as a dose of 600 mg/12 hours. Patients will be monitored and a detailed documentation of any adverse effect due to ALA therapy will be recorded.
This intervention represents an added treatment to the existing standard of care. All patients will continue to receive standard treatment, which is determined by the attending physician who maintains clinical responsibility for all patients. It consists of patient resuscitation, gastric decontamination (with sodium bicarbonate, and activated charcoal [1 g/Kg, orally] in the first 6 hours after onset of poisoning), adequate hydration and supportive treatment. All the patients will be followed up until discharge or death. All patients will be subjected to:
- History. II. Clinical examination. III. Laboratory investigations: At admission and repeated before discharge.
- Conditions
- Toxicity
- Being tested
- Alpha Lipoic Acid (Thioctacid), Placebo (for Alpha Lipoic Acid)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha Lipoic Acid (Thioctacid)Drug
Also called Thioctic Acid
600 mg/12 hours, IV (in the vein)
Placebo (for Alpha Lipoic Acid)Drug
Normal saline in syringe simulating Alpha Lipoic Acid 600mg
| Study group | Role | What they receive |
|---|---|---|
| Alpha Lipoic Acid | Active comparator | Subjects in this arm will receive ALA IV, as a dose of 600 mg/12 hours. Receives: Drug: Alpha Lipoic Acid (Thioctacid) |
| Non-Alpha Lipoic Acid | Placebo comparator | Subjects in this arm will to receive standard treatment only (without Alpha Lipoic Acid, instead they will receive placebo , which is determined by the attending physician who maintains clinical responsibility for all patients. It consists of patient resuscitation, gastric decontamination (with sodium bicarbonate, and activated charcoal [1 g/Kg, orally] in the first 6 hours after onset of poisoning), adequate hydration and supportive treatment. Receives: Drug: Placebo (for Alpha Lipoic Acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death Rate
Measured: 2 years
Secondary outcomes (1)
Duration of hospital stay
Duration that patient will stay in hospital
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToxicityStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heba Allah Ali Abd El-Halim Mabrouk
- Sponsor type
- University, hospital or other
- Collaborators
- Tanta University
- Responsible party
- Sponsor-investigator, Heba Allah Ali Abd El-Halim Mabrouk, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760823
- Sponsor's protocol ID
- ALA-2016-CT
- Other IDs
- ALA
- Acronym
- ALA
- Status last verified
- May 2016
- First submitted
- 2 May 2016
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpha Lipoic Acid as an Adjuvant Treatment in Acute Phosphide Poisoning: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02760823
- Acronym / sponsor ID
- ALA / ALA-2016-CT
- Conditions
- Toxicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Heba Allah Ali Abd El-Halim MabroukUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- May 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 4 May 2016 (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.
The aim of this study is to evaluate efficacy and safety of Alpha Lipoic Acid(ALA) as an adjuvant in the management of patients with acute phosphide poisoning.
Detailed description
The study will be carried out following approval of the research ethical committee of Tanta Faculty of Medicine on patients admitted to The Poison Control Unit (Emergency Hospital, Tanta University and Emergency Hospital, Mansoura University) with acute phosphide poisoning in the period from January 2016 to January 2018. A written informed consent will be taken from each patient or his/her guardians (if the patient was unable to participate in the consent process). Confidentiality of the data will be maintained by making code numbers for each patient. The investigators plan to conduct a randomized clinical trial to evaluate efficacy and safety of ALA as an adjuvant in treatment of patients with acute phosphide poisoning. Fifty patients will be randomized to ALA or a non ALA in a 1:1 ratio (25 patients in each group). ALA will be given IV, as a dose of 600 mg/12 hours. Patients will be monitored and a detailed documentation of any adverse effect due to ALA therapy will be recorded.
This intervention represents an added treatment to the existing standard of care. All patients will continue to receive standard treatment, which is determined by the attending physician who maintains clinical responsibility for all patients. It consists of patient resuscitation, gastric decontamination (with sodium bicarbonate, and activated charcoal [1 g/Kg, orally] in the first 6 hours after onset of poisoning), adequate hydration and supportive treatment. All the patients will be followed up until discharge or death. All patients will be subjected to:
- History. II. Clinical examination. III. Laboratory investigations: At admission and repeated before discharge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpha Lipoic Acid | Active comparator | Drug: Alpha Lipoic Acid (Thioctacid)Subjects in this arm will receive ALA IV, as a dose of 600 mg/12 hours. |
| Non-Alpha Lipoic Acid | Placebo comparator | Drug: Placebo (for Alpha Lipoic Acid)Subjects in this arm will to receive standard treatment only (without Alpha Lipoic Acid, instead they will receive placebo , which is determined by the attending physician who maintains clinical responsibility for all patients. It consists of patient resuscitation, gastric decontamination (with sodium bicarbonate, and activated charcoal [1 g/Kg, orally] in the first 6 hours after onset of poisoning), adequate hydration and supportive treatment. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients (male or female, aged 12 years or older) with symptomatic acute phosphide poisoning (deliberate or accidental), with diagnosis made on the basis of:
- The typical clinical manifestations due to and following shortly after a single exposure to phosphide.
- Reliable identification of the compound based on the container brought by patient attendants or a subsequent confirmation by silver nitrate test for phosphine detection in stomach contents.
Key exclusion criteria (6 listed)
- Patients less than 12 years of age
- Pregnant and lactating women
- Patients with ingestion or exposure to other substances in addition to phosphide.
- Patients with other major medical conditions (e.g. cardiovascular disease, renal or hepatic failure).
- Patients presenting more than 6 hours of having consumed the phosphide compound (late presenters).
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 |
|---|---|---|
| Alpha Lipoic Acid (Thioctacid)Also: Thioctic Acid600 mg/12 hours, IV (in the vein) | Drug | Alpha Lipoic Acid |
| Placebo (for Alpha Lipoic Acid)Normal saline in syringe simulating Alpha Lipoic Acid 600mg | Drug | Non-Alpha Lipoic Acid |
Primary outcome
Mortality
Time frame: 2 years
Death Rate
1 secondary outcome
Duration of hospital stay
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alpha Lipoic Acid (Thioctacid) in people with Toxicity, run by Heba Allah Ali Abd El-Halim Mabrouk.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Mortality (time frame: 2 years). 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 10 May 2016.