Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609001046291
Ethics application status
Approved
Date submitted
4/12/2009
Date registered
8/12/2009
Date last updated
22/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
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)
Scientific title
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.
Secondary ID [1] 283963 0
No known secondary IDs
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vitamin D deficiency 252344 0
Condition category
Condition code
Musculoskeletal 252535 252535 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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)
Intervention code [1] 255657 0
Treatment: Other
Comparator / control treatment
Group 3- vitamin D capsules, administered orally, once a day for 28 days (concentration 1000 IU, 25 mcg)

Group 4- vitamin D capsules, administered orally, once a day for 28 days (concentration 5000 IU, 125 mcg)
Control group
Active

Outcomes
Primary outcome [1] 253417 0
To determine if vitamin D/TPM formulations show improved bioavailability compared to vitamin D supplementation alone
Timepoint [1] 253417 0
Days 1, 2, 4, 7, 14, 21 and 28.
Secondary outcome [1] 262525 0
To assess the safety and tolerability of various formulations of vitamin D.
Clinical Laboratory Testing
Timepoint [1] 262525 0
Days 1, 7 , 14, 28 and follow-up.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be randomly allocated to a study treatment via an online ‘randomising’ program (computer sequence generator). Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/01/2010
Actual
26/10/2010
Date of last participant enrolment
Anticipated
Actual
16/12/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256135 0
Commercial sector/Industry
Name [1] 256135 0
Phosphagenics Limited
Country [1] 256135 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Phosphagenics Limited
Address
11 Duerdin Street
Clayton VIC
3168
Country
Australia
Secondary sponsor category [1] 251475 0
None
Name [1] 251475 0
Address [1] 251475 0
Country [1] 251475 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258226 0
Southern Health Human Research Ethics Committee
Ethics committee address [1] 258226 0
Ethics committee country [1] 258226 0
Date submitted for ethics approval [1] 258226 0
03/12/2009
Approval date [1] 258226 0
Ethics approval number [1] 258226 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30583 0
Dr Roksan Libinaki
Address 30583 0
Phosphagenics Ltd
11 Duerdin St
Clayton, 3168
VICTORIA
Country 30583 0
Australia
Phone 30583 0
+61 3 9565 1119
Fax 30583 0
Email 30583 0
[email protected]
Contact person for public queries
Name 13830 0
Yelda Ogru
Address 13830 0
Phosphagenics Ltd
Phosphagenics Ltd
11 Duerdin St
Clayton, 3168
VICTORIA
Country 13830 0
Australia
Phone 13830 0
61 3 9565 1156
Fax 13830 0
Email 13830 0
[email protected]
Contact person for scientific queries
Name 4758 0
Yelda Ogru
Address 4758 0
Phosphagenics Ltd
11 Duerdin St
Clayton, 3168
VICTORIA
Country 4758 0
Australia
Phone 4758 0
61 3 9565 1156
Fax 4758 0
Email 4758 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.