NCT04935034

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 15, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 22, 2021

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.9 years

First QC Date

June 15, 2021

Last Update Submit

September 12, 2024

Conditions

Vitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Vitamin D enriched mixed micelles dairy drink

EXPERIMENTAL

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

Dietary Supplement: Vitamin D supplement

Vitamin D enriched olive oil dairy drink

ACTIVE COMPARATOR

20ug vitamin D in olive oil dairy drink

Dietary Supplement: Vitamin D supplement

Vitamin D enriched fish oil dairy drink

ACTIVE COMPARATOR

20ug vitamin D in fish oil dairy drink

Dietary Supplement: Vitamin D supplement

Vitamin D enriched fat-free dairy drink

ACTIVE COMPARATOR

20ug vitamin D in fat-free dairy drink

Dietary Supplement: Vitamin D supplement

Interventions

Vitamin D supplementDIETARY_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 drinkVitamin D enriched fish oil dairy drinkVitamin D enriched mixed micelles dairy drinkVitamin D enriched olive oil dairy drink

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy men and women

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College Dublin

Dublin, Ireland

Location

MeSH Terms

Conditions

Vitamin D Deficiency

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single-blinded crossover study
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: The is a 4 arm single-blinded crossover study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 15, 2021

First Posted

June 22, 2021

Study Start

July 1, 2018

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

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.

Locations

IE(1)