Megaloblastic Anemia NosPhase 4NCT03372447
Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia
A Phase 4 study testing Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg in people with Megaloblastic Anemia Nos and Pernicious Anemia, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial summary
Demonstrate the effectiveness of a single dose of a multivitamin complex for the treatment of megaloblastic anemia Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Megaloblastic Anemia Nos, Pernicious Anemia
- What is being tested?
- Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteMexico
- Study dates
- 27 Dec 2017to 1 Dec 2019
- Phase
- Phase 4
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18, All sex Clinical suspicious of megaloblastic anemia ( cytopenias and macrocytosis (CBC), hypersegmented neutrophils and elevated lactate dehydrogenase) Patients must sign an informed consent indicating that they are aware of the investigational nature of this study -
Who cannot join
- Administration of hydroxocobalamin in the three years before enrollment Patients with active, uncontrolled psychiatric disorders Severe neurologic deficit Known hematologic malignancy Known coagulation disorder that contraindicates intramuscular injection End-stage kidney disease (GFR <15ml/min) Chronic liver disease (Child-Pugh B or C) Pregnant patients Known infection of Hepatitis B or C and HIV Diagnosis of myelodysplastic syndrome
- -
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario Dr. Jose E Gonzalez UANL
Monterrey, Nuevo León, 64460
About this study
Official title: Megadose of Hydroxocobalamin (Vitamin B12) for the Treatment of Pernicious Anemia
Demonstrate the effectiveness of a single dose of a multivitamin complex for the treatment of megaloblastic anemia
Read the detailed description
The investigators will administrate a single intramuscular dose of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg.
To assess response to treatment, a complete blood count (CBC) will be performed weekly during the first month of treatment, after the first month a CBC will be taken monthly for 6 months.
Also to confirm the diagnosis and assess response the investigators will measure levels of methylmalonic acid, homocysteine, and hydroxocobalamin at the beginning of the study, 3 and 6 months.
- Conditions
- Megaloblastic Anemia Nos, Pernicious Anemia
- Being tested
- Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg
- Medical subject headings
- Anemia, Megaloblastic, Anemia, Pernicious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mgDrug
Also called Bedoyecta Tri
Single intramuscular dose of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg.
| Study group | Role | What they receive |
|---|---|---|
| Megadose multivitamin complex | Experimental | Intramuscular injection of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg Receives: Drug: Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematologic response
Normalization of complete blood count (CBC).
Measured: 2 month
Duration of hematologic response
Duration of response (months) after the administration of megadose of hydroxocobalamin
Measured: 6 months
Secondary outcomes (4)
Measure levels of hydroxocobalamin
Measured: Basal, three and six months
Measure levels of methylmalonic acid.
Measured: Basal, three and six months
Measure levels of homocysteine.
Measured: Basal, three and six months
Evaluate time to hematologic response
Time to response after the administration of 10,000mcg hydroxocobalamin
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start27 Dec 2017
- Primary completion1 Dec 2018
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Megaloblastic Anemia NosStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- David Gómez Almaguer, MD, Study chair, Hospital Universitario Dr. José Eleuterio González
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372447
- Sponsor's protocol ID
- HE17-00023
- Status last verified
- Mar 2021
- First submitted
- 5 Dec 2017
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans for a sharing plan pre-determined
Publications
Sanz-Cuesta T, Gonzalez-Escobar P, Riesgo-Fuertes R, Garrido-Elustondo S, del Cura-Gonzalez I, Martin-Fernandez J, Escortell-Mayor E, Rodriguez-Salvanes F, Garcia-Solano M, Gonzalez-Gonzalez R, Martin-de la Sierra-San Agustin MA, Olmedo-Luceron C, Sevillano Palmero ML, Mateo-Ruiz C, Medina-Bustillo B, Valdivia-Perez A, Garcia-de Blas-Gonzalez F, Marino-Suarez JE, Rodriguez-Barrientos R, Ariza-Cardiel G, Cabello-Ballesteros LM, Polentinos-Castro E, Rico-Blazquez M, Rodriguez-Monje MT, Soto-Diaz S, Martin-Iglesias S, Rodriguez-Gonzalez R, Breton-Lesmes I, Vicente-Herrero M, Sanchez-Diaz J, Gomez-Gascon T, Drake-Canela M, Asunsolo-del Barco A; OB12 Group. Oral versus intramuscular administration of vitamin B12 for the treatment of patients with vitamin B12 deficiency: a pragmatic, randomised, multicentre, non-inferiority clinical trial undertaken in the primary healthcare setting (Project OB12). BMC Public Health. 2012 May 31;12:394. doi: 10.1186/1471-2458-12-394.
PubMed 22650964Stabler SP. Vitamin B12 deficiency. N Engl J Med. 2013 May 23;368(21):2041-2. doi: 10.1056/NEJMc1304350. No abstract available.
PubMed 23697526Green R. Vitamin B12 deficiency from the perspective of a practicing hematologist. Blood. 2017 May 11;129(19):2603-2611. doi: 10.1182/blood-2016-10-569186. Epub 2017 Mar 30.
PubMed 28360040Sharabi A, Cohen E, Sulkes J, Garty M. Replacement therapy for vitamin B12 deficiency: comparison between the sublingual and oral route. Br J Clin Pharmacol. 2003 Dec;56(6):635-8. doi: 10.1046/j.1365-2125.2003.01907.x.
PubMed 14616423
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Megadose of Hydroxocobalamin (Vitamin B12) for the Treatment of Pernicious Anemia
- ClinicalTrials.gov ID
- NCT03372447
- Acronym / sponsor ID
- HE17-00023
- Conditions
- Megaloblastic Anemia Nos, Pernicious Anemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Study start
- 27 Dec 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 13 Dec 2017 (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.
Demonstrate the effectiveness of a single dose of a multivitamin complex for the treatment of megaloblastic anemia
Detailed description
The investigators will administrate a single intramuscular dose of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg.
To assess response to treatment, a complete blood count (CBC) will be performed weekly during the first month of treatment, after the first month a CBC will be taken monthly for 6 months.
Also to confirm the diagnosis and assess response the investigators will measure levels of methylmalonic acid, homocysteine, and hydroxocobalamin at the beginning of the study, 3 and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Megadose multivitamin complex | Experimental | Drug: Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mgIntramuscular injection of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age >18, All sex Clinical suspicious of megaloblastic anemia ( cytopenias and macrocytosis (CBC), hypersegmented neutrophils and elevated lactate dehydrogenase) Patients must sign an informed consent indicating that they are aware of the investigational nature of this study -
Key exclusion criteria (2 listed)
- Administration of hydroxocobalamin in the three years before enrollment Patients with active, uncontrolled psychiatric disorders Severe neurologic deficit Known hematologic malignancy Known coagulation disorder that contraindicates intramuscular injection End-stage kidney disease (GFR <15ml/min) Chronic liver disease (Child-Pugh B or C) Pregnant patients Known infection of Hepatitis B or C and HIV Diagnosis of myelodysplastic syndrome
- -
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 |
|---|---|---|
| Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mgAlso: Bedoyecta TriSingle intramuscular dose of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg. | Drug | Megadose multivitamin complex |
Primary outcome
Hematologic response
Time frame: 2 month
Normalization of complete blood count (CBC).
Duration of hematologic response
Time frame: 6 months
Duration of response (months) after the administration of megadose of hydroxocobalamin
4 secondary outcomes
Measure levels of hydroxocobalamin
Time frame: Basal, three and six months
Measure levels of methylmalonic acid.
Time frame: Basal, three and six months
Measure levels of homocysteine.
Time frame: Basal, three and six months
Evaluate time to hematologic response
Time frame: 1 month
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 8 Mar 2021.
- Results publication: PubMed 22650964Sanz-Cuesta T, Gonzalez-Escobar P, Riesgo-Fuertes R, Garrido-Elustondo S, del Cura-Gonzalez I, Martin-Fernandez J, Escortell-Mayor E, Rodriguez-Salvanes F, Garcia-Solano M, Gonzalez-Gonzalez R, Martin-de la Sierra-San Agustin MA, Olmedo-Luceron C, Sevillano Palmero ML, Mateo-Ruiz C, Medina-Bustillo B, Valdivia-Perez A, Garcia-de Blas-Gonzalez F, Marino-Suarez JE, Rodriguez-Barrientos R, Ariza-Cardiel G, Cabello-Ballesteros LM, Polentinos-Castro E, Rico-Blazquez M, Rodriguez-Monje MT, Soto-Diaz S, Martin-Iglesias S, Rodriguez-Gonzalez R, Breton-Lesmes I, Vicente-Herrero M, Sanchez-Diaz J, Gomez-Gascon T, Drake-Canela M, Asunsolo-del Barco A; OB12 Group. Oral versus intramuscular administration of vitamin B12 for the treatment of patients with vitamin B12 deficiency: a pragmatic, randomised, multicentre, non-inferiority clinical trial undertaken in the primary healthcare setting (Project OB12). BMC Public Health. 2012 May 31;12:394. doi: 10.1186/1471-2458-12-394.
- Results publication: PubMed 23697526Stabler SP. Vitamin B12 deficiency. N Engl J Med. 2013 May 23;368(21):2041-2. doi: 10.1056/NEJMc1304350. No abstract available.
- Results publication: PubMed 28360040Green R. Vitamin B12 deficiency from the perspective of a practicing hematologist. Blood. 2017 May 11;129(19):2603-2611. doi: 10.1182/blood-2016-10-569186. Epub 2017 Mar 30.
- Results publication: PubMed 14616423Sharabi A, Cohen E, Sulkes J, Garty M. Replacement therapy for vitamin B12 deficiency: comparison between the sublingual and oral route. Br J Clin Pharmacol. 2003 Dec;56(6):635-8. doi: 10.1046/j.1365-2125.2003.01907.x.
- Individual participant dataSharing planned: No. No plans for a sharing plan pre-determined
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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.
David Gómez Almaguer, MD study chair
Hospital Universitario Dr. José Eleuterio González
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg in people with Megaloblastic Anemia Nos and Pernicious Anemia, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
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 1 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 8 Mar 2021. 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 Mexico. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Hematologic response (time frame: 2 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03372447, which also lists 4 linked publications.
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 8 Mar 2021.