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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
  Purpose

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


Condition Intervention
Healthy Individuals
Dietary Supplement: Group 1
Dietary Supplement: Group 2
Dietary Supplement: group 3
Dietary Supplement: Group 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 120
Study Start Date: January 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Skimmilk enriched with VD encapsulated in CM Dietary Supplement: Group 1
Skimmilk enriched with VD encapsulated in CM
Active Comparator: VD will be dissolved in milkfat and homogenized into skimmilk
VD will be dissolved in milkfat and homogenized into skimmilk
Dietary Supplement: Group 2
VD will be dissolved in milkfat and homogenized into skimmilk
Active Comparator: 3% fat milk wherein the VD will be in CM
3% fat milk wherein the VD will be in CM
Dietary Supplement: group 3
3% fat milk wherein the VD will be in CM
Active Comparator: Placebo: un-enriched skimmilk.
Placebo: un-enriched skimmilk.
Dietary Supplement: Group 4
Placebo: un-enriched skimmilk.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers

Exclusion Criteria:

  • Metabolic disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Sophia Ish-Shalom, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01259570     History of Changes
Other Study ID Numbers: 3000007066
Study First Received: December 12, 2010
Last Updated: December 13, 2010
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on November 24, 2014