ToxicityEarly Phase 1NCT03953248
L-Carnitine as an Adjuvant Treatment in Acute Phosphide Poisoning (LC)
A Early Phase 1 study testing L-Carnitine in people with Toxicity, run by Heba Allah Ali Abd El-Halim Mabrouk.
Trial summary
The aim of this study was 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?
- L-Carnitine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2018
- Phase
- Early Phase 1
- 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: L-Carnitine as an Adjuvant Treatment in Acute Phosphide Poisoning (LC): A Randomized Clinical Trial
The aim of this study was 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 was carried out following approval of the research ethical committee of Tanta Faculty of Medicine on patients admitted to The Poison Control Unit (Emergency Hospitals, Tanta and Mansoura Universities) with acute phosphide poisoning in the period from January 2016 to January 2018. A written informed consent was taken from each patient or his/her guardians (if the patient was unable to participate in the consent process). Confidentiality of the data was maintained by making code numbers for each patient. The investigators planned to conduct a randomized clinical trial to evaluate efficacy and safety of LC as an adjuvant in treatment of patients with acute phosphide poisoning. Fifty patients was randomized to LC or a non LC in a 1:1 ratio (25 patients in each group). LC was given IV, as a dose of 1 g/8 hours. Patients was monitored and a detailed documentation of any adverse effect due to LC therapy was recorded.
This intervention represented an added treatment to the existing standard of care. All patients will continue to receive standard treatment, which was determined by the attending physician who maintained clinical responsibility for all patients. It consisted 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 was followed up until discharge or death. All patients was subjected to:
- History. II. Clinical examination. III. Laboratory investigations: At admission and repeated before discharge.
- Conditions
- Toxicity
- Being tested
- L-Carnitine
- Keywords
- phosphide; poisoning; L-carnitine; oxidative stress
- Medical subject headings
- Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-CarnitineDrug
| Study group | Role | What they receive |
|---|---|---|
| Non L-Carnitine | No intervention | Subjects in this arm will receive standard treatment only (without LC). 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 |
| L-Carnitine | Active comparator | Subjects in this arm will receive standard treatment in addition to LC IV, as a dose of 1 g/8 hours Receives: Drug: L-Carnitine |
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 posted16 May 2019
- Study startJan 2016
- Primary completionJan 2018
- Study completionJan 2018
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
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
- NCT03953248
- Sponsor's protocol ID
- LC-2018-CT
- Other IDs
- L-Carnitine
- Status last verified
- May 2019
- First submitted
- 14 May 2019
- Last updated
- 16 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-Carnitine as an Adjuvant Treatment in Acute Phosphide Poisoning (LC): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03953248
- Acronym / sponsor ID
- LC-2018-CT
- Conditions
- Toxicity
- Keywords
- phosphide; poisoning; L-carnitine; oxidative stress
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Heba Allah Ali Abd El-Halim MabroukUniversity, hospital or other
- Collaborators
- Tanta University
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 16 May 2019 (actual)
- 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 was 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 was carried out following approval of the research ethical committee of Tanta Faculty of Medicine on patients admitted to The Poison Control Unit (Emergency Hospitals, Tanta and Mansoura Universities) with acute phosphide poisoning in the period from January 2016 to January 2018. A written informed consent was taken from each patient or his/her guardians (if the patient was unable to participate in the consent process). Confidentiality of the data was maintained by making code numbers for each patient. The investigators planned to conduct a randomized clinical trial to evaluate efficacy and safety of LC as an adjuvant in treatment of patients with acute phosphide poisoning. Fifty patients was randomized to LC or a non LC in a 1:1 ratio (25 patients in each group). LC was given IV, as a dose of 1 g/8 hours. Patients was monitored and a detailed documentation of any adverse effect due to LC therapy was recorded.
This intervention represented an added treatment to the existing standard of care. All patients will continue to receive standard treatment, which was determined by the attending physician who maintained clinical responsibility for all patients. It consisted 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 was followed up until discharge or death. All patients was 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 |
|---|---|---|
| Non L-Carnitine | No intervention | –Subjects in this arm will receive standard treatment only (without LC). 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 |
| L-Carnitine | Active comparator | Drug: L-CarnitineSubjects in this arm will receive standard treatment in addition to LC IV, as a dose of 1 g/8 hours |
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 (4 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).
- Patients treated for acute phosphide poisoning in any medical center before admission
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 |
|---|---|---|
| L-Carnitine | Drug | L-Carnitine |
Primary outcome
Mortality
Time frame: 2 years
Death Rate
1 secondary outcome
Duration of hospital stay
Time frame: 2 years
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 16 May 2019.
- Individual participant dataSharing planned: Yes
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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 Early Phase 1 study testing L-Carnitine 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 4 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 16 May 2019. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
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 16 May 2019.