Medlab NanoCelle™ D3 hormone blood level absorption study in healthy adult volunteers.

Phase 1

Withdrawn

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

• Registration Number: ACTRN12618001177246
• Lead Sponsor: Medlab Clinical Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-16
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

1.Participants greater than or equal to 18 years of age at time of entry on study;
2.No evidence or documented history of a chronic disease;
3.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 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 or planning to become pregnant;
5.The current use of any nicotine products including:
i)nicotine patches / gum;
ii)tobacco smoking;
6.History of 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, sarcoidosis, hyperparathyroidism, histoplasmosis.
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]
9.Vegetarianism

Study & Design

• Study Type: Interventional
• Study Design: Not specified