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

NCT ID: NCT04935034

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2021-05-31

Brief Summary

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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

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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.

Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

The is a 4 arm single-blinded crossover study
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants
single-blinded crossover study

Study Groups

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Vitamin D enriched mixed micelles dairy drink

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

Group Type EXPERIMENTAL

Vitamin D supplement

Intervention Type DIETARY_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.

Vitamin D enriched olive oil dairy drink

20ug vitamin D in olive oil dairy drink

Group Type ACTIVE_COMPARATOR

Vitamin D supplement

Intervention Type DIETARY_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.

Vitamin D enriched fish oil dairy drink

20ug vitamin D in fish oil dairy drink

Group Type ACTIVE_COMPARATOR

Vitamin D supplement

Intervention Type DIETARY_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.

Vitamin D enriched fat-free dairy drink

20ug vitamin D in fat-free dairy drink

Group Type ACTIVE_COMPARATOR

Vitamin D supplement

Intervention Type DIETARY_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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University College Dublin

OTHER

Sponsor Role lead

Responsible Party

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Aifric O'Sullivan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University College Dublin

Dublin, , Ireland

Site Status

Countries

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Ireland

Other Identifiers

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LS-20-53-OSullivan-McCourt

Identifier Type: -

Identifier Source: org_study_id

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