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Food-based Solutions for Optimal Vitamin D Nutrition and Health (ODIN_FOOD)

Primary Purpose

Vitamin D Deficiency

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Non-fortified foods
Fortified foods
Sponsored by
Technical University of Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin D Deficiency focused on measuring Vitamin D, Fortification

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 18-50 year old women
  • Low consumption of fish and fish products
  • Low intake of vitamin D containing supplements
  • No use of sunning facilities
  • No planned sun-holiday between October 2015 and May 2016

Exclusion Criteria:

  • Pregnancy and breastfeeding
  • Menopause
  • Serious diseases (cancer, server liver or kidney insufficiencies, sarcoidosis and other granulomatous diseases) and medicines affecting the vitamin D metabolism (steroids, antiepileptic, thyroid hormones, bisphosphonates, oestrogen).

Sites / Locations

  • Technical University of Denmark

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Non-fortified foods SA

Non-fortified foods CA

Vitamin D fortified foods SA

Vitamin D fortified foods CA

Arm Description

Non-fortified foods (eggs, cheese, yoghurt, crips bread) (placebo), women of South Asian (SA) origin

Non-fortified foods (eggs, cheese, yoghurt, crips bread) (placebo), women of Caucasian (CA) origin

Vitamin D fortified foods (eggs, cheese, yoghurt, crips bread), women of South Asian (SA) origin

Vitamin D fortified foods (eggs, cheese, yoghurt, crips bread), women of Caucasian (CA) origin

Outcomes

Primary Outcome Measures

The change in vitamin D status measured as serum 25-hydroxyvitamin D

Secondary Outcome Measures

Full Information

First Posted
November 11, 2015
Last Updated
October 17, 2016
Sponsor
Technical University of Denmark
Collaborators
Seventh Framework Programme
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1. Study Identification

Unique Protocol Identification Number
NCT02631629
Brief Title
Food-based Solutions for Optimal Vitamin D Nutrition and Health
Acronym
ODIN_FOOD
Official Title
Food-based Solutions for Optimal Vitamin D Nutrition and Health
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Denmark
Collaborators
Seventh Framework Programme

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This project aims at proving the efficacy and safety of food based solutions to prevent vitamin D deficiency in high risk populations of Caucasian and South Asian origin living in Denmark.
Detailed Description
The study is a 12 week double-blinded, randomised, placebo-controlled food-based intervention trial in a real-life setting. 140 (18-50 y) women in risk of vitamin D deficiency and with Caucasian or South Asian origin. The two ethnic groups of women will each be randomised into two groups. One receiving vitamin D fortified foods and the other receiving the same kind of foods non-fortified. Foods given in the study period are free of charge for the participants and will be handed out every second week. The foods are eggs, yoghurt, cheese and crisp bread. The study includes a baseline visit and a final visit, at both visits blood samples will be drawn, anthropometrics, muscle strengths, dietary and background questionnaires.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-fortified foods SA
Arm Type
Placebo Comparator
Arm Description
Non-fortified foods (eggs, cheese, yoghurt, crips bread) (placebo), women of South Asian (SA) origin
Arm Title
Non-fortified foods CA
Arm Type
Placebo Comparator
Arm Description
Non-fortified foods (eggs, cheese, yoghurt, crips bread) (placebo), women of Caucasian (CA) origin
Arm Title
Vitamin D fortified foods SA
Arm Type
Active Comparator
Arm Description
Vitamin D fortified foods (eggs, cheese, yoghurt, crips bread), women of South Asian (SA) origin
Arm Title
Vitamin D fortified foods CA
Arm Type
Active Comparator
Arm Description
Vitamin D fortified foods (eggs, cheese, yoghurt, crips bread), women of Caucasian (CA) origin
Intervention Type
Other
Intervention Name(s)
Non-fortified foods
Intervention Description
The non-fortified placebo foods are eggs, cheese, yoghurt and crisp bread (without vitamin D added).
Intervention Type
Other
Intervention Name(s)
Fortified foods
Intervention Description
The fortified intervention foods are eggs, cheese, yoghurt and crisp bread (with about 20 mcg/day).
Primary Outcome Measure Information:
Title
The change in vitamin D status measured as serum 25-hydroxyvitamin D
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-50 year old women Low consumption of fish and fish products Low intake of vitamin D containing supplements No use of sunning facilities No planned sun-holiday between October 2015 and May 2016 Exclusion Criteria: Pregnancy and breastfeeding Menopause Serious diseases (cancer, server liver or kidney insufficiencies, sarcoidosis and other granulomatous diseases) and medicines affecting the vitamin D metabolism (steroids, antiepileptic, thyroid hormones, bisphosphonates, oestrogen).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Inge Tetens, Professor
Organizational Affiliation
Technical University of Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Technical University of Denmark
City
Søborg
ZIP/Postal Code
2860
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30852657
Citation
Gronborg IM, Tetens I, Christensen T, Andersen EW, Jakobsen J, Kiely M, Cashman KD, Andersen R. Vitamin D-fortified foods improve wintertime vitamin D status in women of Danish and Pakistani origin living in Denmark: a randomized controlled trial. Eur J Nutr. 2020 Mar;59(2):741-753. doi: 10.1007/s00394-019-01941-6. Epub 2019 Mar 9.
Results Reference
derived

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Food-based Solutions for Optimal Vitamin D Nutrition and Health

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