Vitamin B12 Blood Level Absorption Study in Healthy Adult Volunteers.

Completed

• Conditions: Vitamin B12 Deficiency; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12616001326482
• Lead Sponsor: Medlab Clinical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-22
• Study Completion: 2017-02-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

1) Participants > 18 years of age at time of entry on study
2) No evidence or documented history of chronic disease
3) Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment
4) Caucasian Ethnicity

Exclusion Criteria

Any clinically relevant abnormal findings which, in the opinion of the investigators / clinicians, may put the participant at risk of adverse events because of participation in the clinical trial including:
1) Previous history of abnormal blood results i.e. FBE, U and E Liver Function Tests and vital signs
2) Use of vitamin or mineral supplements 1 week before the study and/or known adverse side effects to supplements
3) Use of pharmaceutical drugs (prescribed or over-the-counter)
4) Female participants who are lactating or pregnant
5) The current use of any nicotine products including:
i) nicotine patches/gum ii) tobacco smoking
6) History or alcohol or substance abuse including the use of any illicit drugs
7) Presence of chronic/acute illnesses including hypertension, high cholesterol, diabetes, obesity, irritable bowel syndrome, inflammatory bowel disease, coeliac disease
8) Any psychiatric disorders by history or examination that would prevent completion of the study or result in possible adverse events for the participant [suicide thoughts or euthanasia requests]
9) Vegetarianism

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absorption Characteristics: Plasma concentration of Vitamin B12[Blood draws at t-0 (baseline), 60, 180, 360 minutes. 4 time points/day over six consecutive days.]

Secondary Outcome Measures

Name	Time	Method
Safety. Clinical Trial Coordinator to monitor participants and any adverse effects. Any adverse effects will be documented in the individuals Case Report Form. Side effects may include (but not limited to); itchy skin, headache and nausea. [Trial Coordinator will monitor each participant and adverse effects from baseline to 6 hours post dose. ]