A phase I randomised repeat dose study in healthy volunteers to determine the oral bioavailability of various formulations of vitamin D in combination with the novel penetration enhancer tocopheryl phosphate mix (TPM)

A phase I randomised repeat dose study in healthy volunteers to test various oral formulations of vitamin D in combination with the novel penetration enhancer tocopheryl phosphate mix (TPM), in order to determine the amount of vitamin D that reaches the blood stream.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609001046291

Enrollment

Registered

2009-12-08

Start date

2010-10-26

Completion date

2010-12-16

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of this study is to see how much and how fast vitamin D is absorbed into the skin when combined with the penetration enhancer tocopheryl phosphate mix (TPM) and to then compare it to vitamin D alone.

Interventions

Group 1- vitamin D in combination with tocopheryl phosphate mix (TPM) oil based, in a capsule form- administered orally, once a day for 28 days (concentration is 1000 IU, 25 mcg vitamin D and 2IU, 1.5 mg TPM) Group 2- vitamin D in combination with tocopheryl phosphate mix (TPM) aqueous based, in a capsule form- administered orally, once a day for 28 days (concentration is 1000 IU, 25 mcg vitamin D and 2IU, 1.5 mg TPM)

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

1. Male or Female aged 18 to 65 years (inclusive). 2. Healthy subjects - healthy subjects are defined as individuals who are free from clinically significant illness or disease as determine by their medical history. 3. Body Mass Index equal or greater than 18 and equal or less than 25 kg/m2. 4. Fluent in the English language. 5. Able to provide written informed consent to participate in the study and is willing to comply with the study procedures. 6. Non-smokers, or has quit at least 3 months prior to administration of the study treatment.

Exclusion criteria

1. Pregnant or breastfeeding. 2. Individuals who smoked an average of one or more cigarette or tobacco form (including cigar) per month in the last 3 months. 3. Individuals with any current medical problems (current is defined as being within the last 3 months prior to administration of the study treatment). 4. Use of any medications or supplements within 14 days of administration of study treatment. 5. Use of any oral or topical vitamin D supplementation within 14 days of administration of study treatment. 6. Exposure to intense solar or artificial ultraviolet (UV)/tanning salons in the 3 months prior to administration of study treatment. 7. Unwilling or unable to avoid UV exposure for the duration of the study.

Outcome results