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

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

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Dietary supplement: Vitamin D supplement

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.

1. mixed micelles
2. olive oil
3. fish oil
4. 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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • University College Dublin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vitamin D enriched mixed micelles dairy drink; 20ug vitamin D in pre-formed mixed micelle dairy drink	Dietary supplement: Vitamin D supplement; This intervention will compare the effect of changing the lipid component of a vitamin D enriched dairy drink on postprandial change in 25OHD concentrations.
Active Comparator: Vitamin D enriched olive oil dairy drink; 20ug vitamin D in olive oil dairy drink	Dietary supplement: Vitamin D supplement; This intervention will compare the effect of changing the lipid component of a vitamin D enriched dairy drink on postprandial change in 25OHD concentrations.
Active Comparator: Vitamin D enriched fish oil dairy drink; 20ug vitamin D in fish oil dairy drink	Dietary supplement: Vitamin D supplement; This intervention will compare the effect of changing the lipid component of a vitamin D enriched dairy drink on postprandial change in 25OHD concentrations.
Active Comparator: Vitamin D enriched fat-free dairy drink; 20ug vitamin D in fat-free dairy drink	Dietary supplement: Vitamin D supplement; This intervention will compare the effect of changing the lipid component of a vitamin D enriched dairy drink on postprandial change in 25OHD concentrations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	8 hours

Collaborators and Investigators

• Sponsor: University College Dublin

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 15, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: LS-20-53-OSullivan-McCourt

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No