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Nascobal (Cyanocobalamin Nasal) - Summary



Cyanocobalamin is a synthetic form of vitamin B12 with equivalent vitamin B12 activity.

Nascobal Nasal Spray is indicated for the maintenance of normal hematologic status in pernicious anemia patients who are in remission following intramuscular vitamin B12 therapy and who have no nervous system involvement.

Nascobal Nasal Spray is also indicated as a supplement for other vitamin B12 deficiencies, including:

   I. Dietary deficiency of vitamin B12 occurring in strict vegetarians (Isolated vitamin B12 deficiency is very rare).

   II. Malabsorption of vitamin B12 resulting from structural or functional damage to the stomach, where intrinsic factor is secreted, or to the ileum, where intrinsic factor facilitates vitamin B12 absorption. These conditions include HIV infection, AIDS, Crohn's disease, tropical sprue, and nontropical sprue (idiopathic steatorrhea, gluten-induced enteropathy). Folate deficiency in these patients is usually more severe than vitamin B12 deficiency.

   III. Inadequate secretion of intrinsic factor, resulting from lesions that destroy the gastric mucosa (ingestion of corrosives, extensive neoplasia), and a number of conditions associated with a variable degree of gastric atrophy (such as multiple sclerosis, HIV infection, AIDS, certain endocrine disorders, iron deficiency, and subtotal gastrectomy). Total gastrectomy always produces vitamin B12 deficiency. Structural lesions leading to vitamin B12 deficiency include regional ileitis, ileal resections, malignancies, etc.

   IV. Competition for vitamin B12 by intestinal parasites or bacteria. The fish tapeworm (Diphyllobothrium latum) absorbs huge quantities of vitamin B12 and infested patients often have associated gastric atrophy. The blind loop syndrome may produce deficiency of vitamin B12 or folate.

   V. Inadequate utilization of vitamin B12. This may occur if antimetabolites for the vitamin are employed in the treatment of neoplasia.

Requirements of vitamin B12 in excess of normal (due to pregnancy, thyrotoxicosis, hemolytic anemia, hemorrhage, malignancy, hepatic and renal disease) can usually be met with intranasal or oral supplementation.

Nascobal Nasal Spray is not suitable for vitamin B12 absorption test (Schilling Test).

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Media Articles Related to Nascobal (Cyanocobalamin Nasal)

Source: MedicineNet Alcohol Abuse and Alcoholism Specialty [2015.07.16]
Title: Anemia
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 7/16/2015 12:00:00 AM

Health Tip: Recognizing Signs of Anemia
Source: MedicineNet Anemia Specialty [2015.06.18]
Title: Health Tip: Recognizing Signs of Anemia
Category: Health News
Created: 6/18/2015 12:00:00 AM
Last Editorial Review: 6/18/2015 12:00:00 AM

Sickle Cell Disease (Sickle Cell Anemia)
Source: MedicineNet Alpha Thalassemia Specialty [2015.05.21]
Title: Sickle Cell Disease (Sickle Cell Anemia)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 5/21/2015 12:00:00 AM

Pernicious Anemia
Source: MedicineNet Vitiligo Specialty [2015.02.06]
Title: Pernicious Anemia
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 2/6/2015 12:00:00 AM

FDA approves extended dosing of Aranesp
Source: The Doctors Lounge - Hematology
FDA has approved every-3-week dosing of Aranesp (darbepoetin alfa) for treatment of chemotherapy - induced anemia.

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Published Studies Related to Nascobal (Cyanocobalamin Nasal)

Vitamin B(12) deficiency is linked with long-term use of proton pump inhibitors in institutionalized older adults: could a cyanocobalamin nasal spray be beneficial? [2010.01]
The purpose of this study was to determine whether institutionalized older individuals taking proton pump inhibitors (PPI) for more than 12 months were more likely to have vitamin B(12) deficiency than individuals not taking PPI, and whether cyanocobalamin nasal spray would improve their vitamin B(12) status...

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Clinical Trials Related to Nascobal (Cyanocobalamin Nasal)

Plasma Holotranscobalamin as Compared to Plasma Cobalamins for Assessment of Vitamin B12 Absorption [Completed]
In the present study the design of the vitamin B12 absorption test, CobaSorb, is further optimised. We investigate which test – measurement of holotranscobalamin or cobalamins – could be used for reflection of vitamin B12 absorption. Furthermore, we prolong the duration of vitamin B12 administration in order to determine the final duration of the vitamin B12 absorption test CobaSorb.

Seventy-eight healthy individuals (age 21-81 years) are treated with three oral doses of 9 microgram cyanocobalamin per day for five successive days. Non-fasting blood samples are collected on day 1-5 before administration of the first dose of vitamin B12 and on day 8. Cobalamins and holotranscobalamin are measured on day 1–5 and 8. The performance of the vitamin B12 absorption test will be evaluated in individuals with borderline or low levels of holotranscobalamin or cobalamins (below the 75% percentiles) using a change larger than 2CV(day to day) of holotranscobalamin (22%) and cobalamins (12%) to indicate a change caused by absorption of the administered vitamin B12.

Cobalamin Supplementation During Infancy; Effect on B-Vitamin Status, Growth and Psychomotor Development [Completed]
Adequate levels of vitamin B12 (cobalamin) is necessary for normal growth and development in infants. We have earlier investigated cobalamin status in healthy children and we observed metabolic evidence of impaired cobalamin status during the first 6 months, but not later in life.

The purpose of this study is to determine if cobalamin supplementation may influence the metabolic profile related to cobalamin status in infants.

How Many Patients Are in Need of Vitamin B12 Injections? [Recruiting]
The clinical consequences of vitamin B12 deficiency include megaloblastic anemia and neurological disorders. Therefore, a proper and timely diagnosis and treatment is important. The use of sensitive biochemical markers such as methylmalonic acid for the diagnosis of vitamin B12 deficiency have increased since the 1980s. Consequently, the number of individuals treated with vitamin B12 has increased significantly.

The objective of this project is to study the actual need for vitamin B12 injections in the group of individuals who have already started treatment. In order to investigate this, the investigators stop vitamin B12 treatment in this group, and look for signs of vitamin B12 deficiency by monitoring changes in biochemical and hematological markers. Furthermore, they will test if the individuals are able to absorb a physiological dose of vitamin B12 using a recently developed absorption test (CobaSorb). If a physiological dose can be absorbed, the vitamin B12 injections can be replaced with tablets. In the end, the investigators hope to be able to divide the patients into three groups:

1. need life long injections with vitamin B12,

2. only need supplementations with a small dose of oral vitamin B12, and

3. no need for further vitamin B12 treatment.

The perspective is that the new information from this study might be used for a future strategy for vitamin B12 treatment.

Can Recombinant Human Intrinsic Factor Be Used for Evaluation of the Vitamin B12 Absorption? [Completed]
Vitamin B12 is an essential nutrient for normal DNA-synthesis and must be supplied by animal products. Vitamin B12 deficiency may cause anemia and irreverible neurological damage. Laboratory tests are used for diagnosis of vitamin B12 deficiency, and following the diagnosis, the cause of the vitamin B12 deficiency has to be clarified. For years a test called Shilling’s test has been used for evaluation of the vitamin B12 absorption. However, the Schilling’s test is no longer easy accessible because of increasing difficulties to obtain the radioactively labeled vitamin B12 requested, and native human intrinsic factor for Schilling’s test II (absorption of vitamin B12 attached to intrinsic factor) is no longer available in most countries. Recently, human intrinsic factor unsaturated with vitamin B12 has been expressed in the plant Arabidopsis thaliana. The purpose of this study was to examine whether recombinant human intrinsic factor is able to promote the uptake of vitamin B12 in patients with evident vitamin B12 deficiency.

Folic Acid and Vitamin B12 in Young Indian Children [Recruiting]
Hypothesis: Supplementation of two recommended daily allowances (RDA) of folic acid with or without simultaneous administration of vitamin B12 reduces the rates of acute lower respiratory tract infections (ALRI), clinical pneumonia and diarrhea.

Design/Methods We will conduct a preventive randomized placebo controlled clinical trial of folic acid and vitamin B12 supplementation in 1000 children aged 6 to 30 months living in a low to middle-income socioeconomic setting in New Delhi, India. Children aged 6-30 months will be identified through a survey. Eligible and willing Children aged 6-30 months will be randomized to 4 treatment groups. Trial to enrollment informed consent will be obtained by the Study Physician/Supervisor. At enrollment a baseline form will be filled and the child weight and length taken. The baseline blood samples will be collected. The supplements will be given daily for 6 months. Morbidity will be ascertained through biweekly home visits by field workers.

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Page last updated: 2015-07-16

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