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Completed

NCT Number: NCT03372447

Megadose of Hydroxocobalamin for the Treatment of Pernicious Anemia

Demonstrate the effectiveness of a single dose of a multivitamin complex for the treatment of megaloblastic anemia

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Key information

Conditions

Megaloblastic Anemia Nos Anemia Anemia, Macrocytic Anemia, Megaloblastic Anemia, Pernicious Avitaminosis Deficiency Diseases Hematologic Diseases Hemic and Lymphatic Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pernicious Anemia Vitamin B 12 Deficiency Vitamin B Deficiency

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario Dr. Jose E Gonzalez UANL

Monterrey, Nuevo León, 64460, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 -

Exclusion criteria

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

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Treatment and study plan

Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg

Drug

Single intramuscular dose of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg.

Other names: Bedoyecta Tri

Primary outcomes

  1. Hematologic response

    Time frame: 2 month

    Normalization of complete blood count (CBC).

  2. Duration of hematologic response

    Time frame: 6 months

    Duration of response (months) after the administration of megadose of hydroxocobalamin

Secondary outcomes

  1. Measure levels of hydroxocobalamin

    Time frame: Basal, three and six months

  2. Measure levels of methylmalonic acid.

    Time frame: Basal, three and six months

  3. Measure levels of homocysteine.

    Time frame: Basal, three and six months

  4. Evaluate time to hematologic response

    Time frame: 1 month

    Time to response after the administration of 10,000mcg hydroxocobalamin

Sponsors and collaborators

Lead sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Other

Registry information

Official study title

Megadose of Hydroxocobalamin (Vitamin B12) for the Treatment of Pernicious Anemia

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Dec 13, 2017
Registry last updated
Mar 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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