Bioavailability of Vitamin D Encapsulated in Casein Micelles, Compared to Its Bioavailability in the Milk-fat, or in a Synthetic Emulsifier Currently Used for Supplementation and Enrichment

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2010 by Rambam Health Care Campus.
Recruitment status was Not yet recruiting

Sponsor:

Collaborator:

Technion, Israel Institute of Technology

Information provided by:

Rambam Health Care Campus

ClinicalTrials.gov Identifier:

NCT01259570

First received: December 12, 2010

Last updated: December 13, 2010

Last verified: December 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	December 12, 2010
Last Updated Date	December 13, 2010
Start Date ^ICMJE	January 2011
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 13, 2010)	Bioavailability of vitamin D encapsulated in casein micelles, compared to its bioavailability in the milk-fat. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] As a model we have chosen nonfat yoghurt. We will prepare yoghurts from 4 milks: (1) Skimmilk enriched with 50,000 IU/150gr VD encapsulated in CM2 ; (2) 3% fat milk wherein same dose of VD - dissolved in milk fat and homogenized into skimmilk; (3) 3% fat milk wherein VD, at same dose, will be in CM; (4) Placebo: unenriched skimmilk. 120 healthy adults aged 18-65 will randomized to 5 groups and receive 150 gr yoghurt. Blood will be drawn before ingestion and on days 1,7,14. 25(OH)D will be det. by
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01259570 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Bioavailability of Vitamin D Encapsulated in Casein Micelles, Compared to Its Bioavailability in the Milk-fat, or in a Synthetic Emulsifier Currently Used for Supplementation and Enrichment
Official Title ^ICMJE	Not Provided
Brief Summary	The encapsulation within CM may improve bioavailability (BA) of vitamin D (VD), even in absence of fat. As a model the investigators have chosen nonfat yoghurt. The investigators will prepare yoghurts from 4 milks: (1) Skimmilk enriched with 50,000 IU/150gr VD encapsulated in CM2 ; (2) 3% fat milk wherein same dose of VD - dissolved in milk fat and homogenized into skimmilk; (3) 3% fat milk wherein VD, at same dose, will be in CM; (4) Placebo: unenriched skimmilk. 120 healthy adults aged 18-65 will randomized to 5 groups and receive 150 gr yoghurt. Blood will be drawn before ingestion and on days 1,7,14. 25(OH)D will be det. by CMIA. In vitro simulated digestion will be studied. Expected results: The BA of VD in CM would not be lower than in fat
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Bio-equivalence Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention
Condition ^ICMJE	Healthy Individuals
Intervention ^ICMJE	Dietary Supplement: Group 1 Skimmilk enriched with VD encapsulated in CM Dietary Supplement: Group 2 VD will be dissolved in milkfat and homogenized into skimmilk Dietary Supplement: group 3 3% fat milk wherein the VD will be in CM Dietary Supplement: Group 4 Placebo: un-enriched skimmilk.
Study Arm (s)	Active Comparator: Skimmilk enriched with VD encapsulated in CM Intervention: Dietary Supplement: Group 1 Active Comparator: VD will be dissolved in milkfat and homogenized into skimmilk VD will be dissolved in milkfat and homogenized into skimmilk Intervention: Dietary Supplement: Group 2 Active Comparator: 3% fat milk wherein the VD will be in CM 3% fat milk wherein the VD will be in CM Intervention: Dietary Supplement: group 3 Active Comparator: Placebo: un-enriched skimmilk. Placebo: un-enriched skimmilk. Intervention: Dietary Supplement: Group 4
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	120
Estimated Completion Date	May 2012
Estimated Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Healthy volunteers Exclusion Criteria: Metabolic disorder
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01259570
Other Study ID Numbers ^ICMJE	3000007066
Has Data Monitoring Committee	No
Responsible Party	Sophia Ish-Shalom, Rambam Health Care Campus
Study Sponsor ^ICMJE	Rambam Health Care Campus
Collaborators ^ICMJE	Technion, Israel Institute of Technology
Investigators ^ICMJE	Not Provided
Information Provided By	Rambam Health Care Campus
Verification Date	December 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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