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Completed

NCT Number: NCT04935034

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College Dublin

Dublin, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vitamin D supplement

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.

Primary outcomes

  1. Change in 25-hydroxyvitamin D (25(OH)D)

    Time frame: 8 hours

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

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 22, 2021
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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