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NCT07029698
Primary efficacy objective: To investigate the effects of a parenterally vitamin B12 combination treatment versus an oral vitamin B12 mono therapy on the vitamin B12 status in female and male patients as determined by the change from baseline in serum vitamin B12 concentration after 4 weeks (28 days) of treatment. Secondary efficacy objectives: To evaluate the effects of a parenterally vitamin B12 combination versus an oral vitamin B12 mono therapy after 4 weeks of treatment on: * Serum holotranscobalamin * Serum homocysteine * Serum methylmalonic acid * Combined vitamin B12 markers (cB12) * Serum folic acid * Serum vitamin B6 * Serum S-adenosylmethione (SAM) * Serum S-adenosylhomocysteine (SAH) * SAM/SAH ratio * WHO-5 Well-Being Index * Medical Outcomes Study Questionnaire Short Form 36 Health Survey (SF-36) * Visual analogue scale (VAS) EQ-5D. Safety objectives: To evaluate the safety and tolerability of oral vitamin B12 mono therapy versus intramuscular vitamin B12 combination.
NCT04048330
Women of reproductive age are a high-risk population for anaemia and micronutrient deficiencies. Evidence supports the role of periconceptional nutrition in the development of adverse pregnancy complications. However, in India, there are limited population-based data to guide evidence-based recommendations and priority setting. The objective of this study is to conduct a population-based biomarker survey of anaemia and vitamin B12 and folate status in women of reproductive age as part of a periconceptional surveillance program in Southern India.
NCT04027959
STUDY DESIGN: Phase I Clinical Trial The researchers set out to assess the effectiveness of transdermal iontophoretic administration of Vitamin B12 (V.B12) under three different skin preparatory conditions. SETTING: James J. Peters Veterans Affairs Medical Center (Bronx, NY) BACKGROUND: Poor skin permeability precludes the use of transdermal route from being used in common clinical practice for rapid and precise administration of medications through intact skin that are expected to have a systemic effect. The researchers determined the relative effectiveness of an unconventional transdermal iontophoresis technique for the administration of Vitamin B12 (V.B12) under three different skin preparatory conditions. METHODS: During this study, Vitamin B12 (V.B12) was administered through the skin of volunteer human research subjects. Iontophoresis was used as transdermal medication delivery modality after pre-treatment of the skin in 3 different ways. The sequence of skin preparations was arranged in a random order for each subject. Method 1 was called "No Prep", serving as the control approach; method 2 was called "Oleic Acid" application to the skin for 40 minutes; and method 3 was hair "Epilation" (e.g. hair removal by plucking). Fifteen milligrams of aqueous solution of V.B12 was administered through intact, previously unused skin of an anterior thigh during all 3 tests. Chemoluminescence, on an automated laboratory reader Advia Centaur-XP, was used to determine the serum concentration of V.B12 prior to and after transdermal iontophoretic delivery. All 3 experiments were performed on the same day within an hour of each other. The subject's blood was drawn prior and 10 minutes after the 20-minute long sessions of transdermal V.B12 iontophoresis. We were able to calculate the increase in serum V.B12 concentration and based on estimated blood volume, the total quantity and percent dose delivered systemically.
NCT02270749
The purpose of this study is to evaluate the most effective treatment for patients who underwent a Roux-en-Y gastric bypass and developed postoperatively a vitamin B12 deficiency.
NCT01661309
Vegetarians are known to be deficient in vitamin B12, due to a lack or absence of dietary animal produce, which can elevate homocysteine. There is strong evidence indicating that elevated plasma total homocysteine (tHcy) is a contributor to chronic conditions, such as primary cardiovascular disease (CVD). The study hypothesis is: There will be a significant decrease in plasma tHcy of vegetarians following the intervention by supplementary vitamin B12 (of the methylcobalamin type) and this will lead to a reduction of the risk of CVD.
NCT01136512
The primary objective is to determine the incidence of Vitamin B12 deficiency in patients on metformin therapy for diabetes.
NCT01584050
Folic acid, a form of the vitamin folate, is added to grain products in Canada to help reduce birth defects. Folic acid is the synthetic form of folate and is very stable (doesn't break down) when added to foods. There are emerging health concerns about chronic folic acid consumption. Recently another more natural form of folate, L-5-methyltetrahydrofolate (L-MTHF) has become available. The investigators plan to conduct a randomized trial in women to determine if supplements containing L-MTHF consumed over three months raises blood folate levels as much as supplements containing folic acid. The investigators hypothesize that L-MTHF will increase red cell folate over 12 weeks to same extent as equimolar folic acid.
NCT00279552
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.