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Absorption Kinetics and Efficacy of Vitamin D Enriched Supplements in Older Adults.

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Vitamin D supplement
Sponsored by
University College Dublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin D Deficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy men and women

Exclusion Criteria:

Less than 18 years old Pregnant or lactating Smokers Individuals that are not free-living e.g. institutes where meals are prepared in bulk such as nursing homes, prisons etc.

An inability to read, write or understand English Following a strict prescribed diet for any reason, insulin dependent diabetes, coeliac disease, Crohn's disease Disease or condition that requires chronic therapeutic nutritional or medical treatment.

Those taking supplemental vitamin D Those who have been on a sun holiday in the last 2 months

Sites / Locations

  • University College Dublin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Arm Label

Vitamin D enriched mixed micelles dairy drink

Vitamin D enriched olive oil dairy drink

Vitamin D enriched fish oil dairy drink

Vitamin D enriched fat-free dairy drink

Arm Description

20ug vitamin D in pre-formed mixed micelle dairy drink

20ug vitamin D in olive oil dairy drink

20ug vitamin D in fish oil dairy drink

20ug vitamin D in fat-free dairy drink

Outcomes

Primary Outcome Measures

Change in 25-hydroxyvitamin D (25(OH)D)
Change in 25(OH)D up to 8 hours after consuming the vitamin D enriched dairy drink

Secondary Outcome Measures

Full Information

First Posted
June 15, 2021
Last Updated
March 3, 2023
Sponsor
University College Dublin
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1. Study Identification

Unique Protocol Identification Number
NCT04935034
Brief Title
Absorption Kinetics and Efficacy of Vitamin D Enriched Supplements in Older Adults.
Official Title
Absorption Kinetics and Efficacy of Vitamin D Enriched Supplements in Older Adults.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University College Dublin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The proposed study will examine vitamin D bioavailability when 20µg of vitamin D is consumed in 5 different forms: i) a vitamin D enriched pre-formed mixed micelle dairy drink ii) a vitamin D enriched olive oil dairy drink iii) a vitamin D enriched fish oil dairy drink iv) a vitamin D enriched fat-free dairy drink
Detailed Description
This postprandial study will recruit healthy males and females aged 18 and over. Upon completion of informed consent procedures and successful screening, the volunteers will complete 4 study visits. Participants will consume a standardised meal the evening before each test day, and will arrive in the morning to the research facility in UCD after an overnight fast of 12 hours. On the study test days, volunteers will be given one of the following vitamin D treatments in a dairy drink, followed by a low-fat breakfast. mixed micelles olive oil fish oil fat-free Participants will also be given a low-fat lunch 5 hours after the supplement is consumed. Volunteers will be cannulated by a trained phlebotomist on arrival, and a fasting blood sample will be taken. Following ingestion of the vitamin D supplements blood samples will be taken at 0,2,4,6, and 8 hours post ingestion. A 10mL sample will be collected at each time point. In total, 60mL of blood will be collected over 24 hours. The participant's food intake will be recorded during the visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitamin D Deficiency

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
The is a 4 arm single-blinded crossover study
Masking
Participant
Masking Description
single-blinded crossover study
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D enriched mixed micelles dairy drink
Arm Type
Experimental
Arm Description
20ug vitamin D in pre-formed mixed micelle dairy drink
Arm Title
Vitamin D enriched olive oil dairy drink
Arm Type
Active Comparator
Arm Description
20ug vitamin D in olive oil dairy drink
Arm Title
Vitamin D enriched fish oil dairy drink
Arm Type
Active Comparator
Arm Description
20ug vitamin D in fish oil dairy drink
Arm Title
Vitamin D enriched fat-free dairy drink
Arm Type
Active Comparator
Arm Description
20ug vitamin D in fat-free dairy drink
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D supplement
Intervention Description
This intervention will compare the effect of changing the lipid component of a vitamin D enriched dairy drink on postprandial change in 25OHD concentrations.
Primary Outcome Measure Information:
Title
Change in 25-hydroxyvitamin D (25(OH)D)
Description
Change in 25(OH)D up to 8 hours after consuming the vitamin D enriched dairy drink
Time Frame
8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy men and women Exclusion Criteria: Pregnant or lactating Smokers Individuals that are not free-living e.g. institutes where meals are prepared in bulk such as nursing homes, prisons etc. An inability to read, write or understand English Following a strict prescribed diet for any reason, insulin dependent diabetes, coeliac disease, Crohn's disease Disease or condition that requires chronic therapeutic nutritional or medical treatment. Those taking supplemental vitamin D Those who have been on a sun holiday in the last 2 months
Facility Information:
Facility Name
University College Dublin
City
Dublin
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
At the start of the study each participant will have a study code assigned to them. All of the data from the trials will be stored using these unique study codes. A file will be set up which will be stored in a location separate to the study data. This file will contain a list which will link each participants contact details to the corresponding ID code. All stored information will be encrypted and protected by a password that only the researcher and PI will know.

Learn more about this trial

Absorption Kinetics and Efficacy of Vitamin D Enriched Supplements in Older Adults.

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