Vitamin D3 Absorption Studies in Healthy Adult Volunteers.

Not Applicable

Completed

• Conditions: Vitamin D3 deficiency; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12616001027404
• Lead Sponsor: Medlab Clinical

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Participants >18 years of age - 80 years of age at time of entry into the study;
1) No evidence or documented history of a chronic disease
2) Cognitive ability to understand informed consent process and to give informed consent to the experimental treatment

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
2) Vital signs
3) The use of any nicotine products including;
i) nicotine patches/gum ii) tobacco smoking
4) Alcohol abuse
5) The use of any illicit drugs
6) Unstable angina not well managed with medication
7) Pregnancy or nursing of an infant
8) Any psychiatric disorders by history or examination that would prevent completion of the study or result in possible adverse events for the participant [i.e. suicide thoughts or euthanasia requests]

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Absorption Characteristics ; plasma concentration of Vitamin D3<br>[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): headache, loss of appetite, dry mouth, nausea and vomitting. [Blood draws at t- 0 (baseline), 60, 180, 360 minutes. 4 time points/day over six consecutive days.]