New vitamin B12 formula tested for better absorption in seniors
NCT ID NCT07665671
First seen Jun 26, 2026 · Last updated Sep 10, 2026 · Updated 7 times
Summary
This Phase IV trial will compare how well a new vitamin B12 supplement (Ampli-B) is absorbed versus standard vitamin B12 in 12 healthy adults aged 50 and older. Each person will take a single dose of both supplements in random order, with a 10-day break in between. The study measures how quickly and how much B12 gets into the blood, aiming to see if the new formulation works better.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Vitamin B12 (as Ampli-B with permeability enhancer and standard cobalamin)
- What this could lead to
- If successful, this could show that a specially formulated vitamin B12 supplement is absorbed faster or better than standard B12, potentially improving supplementation options.
- What could go wrong
- This is a very small, early-stage trial in only 12 healthy volunteers, so results may not apply to people with B12 deficiency or other health conditions. The study is not yet recruiting.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
12 people
The number who actually took part.
- Started
-
Jul 2026
- Finished
-
Aug 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
50 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males and females 50 years of age and older 2. BMI between 18 to 29.9 kg/m2 3. Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or, Woman of child-bearing potential (WOCBP) must be following appropriate contraceptive methods until the last visit: * Sexual abstinence. * Oral contraceptive. * Trans dermal patches or depot injection of a progestogen drug (starting at least 4 weeks prior to product administration). * Intrauterine device (IUD), intrauterine system (IUS), subdermal implant, or vaginal ring (placed at least 4 weeks prior to product administration). * Sterilised male partner (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). * Contraceptives must be effective before product administration. 4. Agrees not to take any vitamin B12 containing supplements until the completion of the study. 5. Agrees to avoid consuming liver, kidney, organ meats and very high B12 containing shellfish (e.g. clams and crab) 72 hours prior to study visits 6. Agrees to consume the standardized meals for each of the study visits 7. Agrees to avoid alcohol intake 48 hours prior to study visits 8. Agrees to maintain current lifestyle habits (physical activity, medications, supplements, and sleep) as much as possible throughout the study 9. Able to fast for 10 hours prior to study visits (visit 1 and visit 3) 10. Provided voluntary, written, informed consent to participate in the study Exclusion Criteria: 1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study 2. Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational products 3. History or current diagnosis of any clinically significant disease that may alter vitamin B12 absorption, accumulation, metabolism or excretion 4. Taking vitamin B12 supplements or a multivitamin supplement containing vitamin B12 within the prior 2 months from study product administration. 5. Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the absorption of vitamin B12 6. Have a serious illness e.g. mood disorders such as depression, anxiety or bipolar disorder, neurological disorders such as MS, kidney disease, diabetes, liver disease, autoimmune disease, bleeding disorders or heart conditions 7. Have an unstable illness e.g. diabetes and thyroid gland dysfunction 8. Current malignancy (excluding Basal Cell Carcinoma) or chemotherapy or radiotherapy treatment for malignancy within the previous 2 years 9. Gastrointestinal or absorption issues (IBD, IBS, Celiac disease, Crohn's disease, history of GI surgery, Small Intestinal Bacterial Overgrowth) 10. Poor venous access 11. Current use of cannabinoid products (\>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period 12. Active smokers, nicotine use or drug (prescription or illegal substances) abuse. 13. Chronic past and/or current alcohol use (\>14 alcoholic drinks week) 14. Blood donation 60 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit 15. Participation in other clinical research studies 30 days prior to baseline, as assessed by the PI 16. Any other condition or lifestyle factor, that, in the opinion of the PI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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RDC Clinical
Brisbane, Queensland, Australia
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