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

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.

Study Overview

• Status: Completed
• Conditions: Vitamin D Deficiency
• Intervention / Treatment: Other: Non-fortified foods; Other: Fortified foods

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.

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Søborg, Denmark, 2860
    • Technical University of Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Non-fortified foods SA; Non-fortified foods (eggs, cheese, yoghurt, crips bread) (placebo), women of South Asian (SA) origin	Other: Non-fortified foods; The non-fortified placebo foods are eggs, cheese, yoghurt and crisp bread (without vitamin D added).
Placebo Comparator: Non-fortified foods CA; Non-fortified foods (eggs, cheese, yoghurt, crips bread) (placebo), women of Caucasian (CA) origin	Other: Non-fortified foods; The non-fortified placebo foods are eggs, cheese, yoghurt and crisp bread (without vitamin D added).
Active Comparator: Vitamin D fortified foods SA; Vitamin D fortified foods (eggs, cheese, yoghurt, crips bread), women of South Asian (SA) origin	Other: Fortified foods; The fortified intervention foods are eggs, cheese, yoghurt and crisp bread (with about 20 mcg/day).
Active Comparator: Vitamin D fortified foods CA; Vitamin D fortified foods (eggs, cheese, yoghurt, crips bread), women of Caucasian (CA) origin	Other: Fortified foods; The fortified intervention foods are eggs, cheese, yoghurt and crisp bread (with about 20 mcg/day).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change in vitamin D status measured as serum 25-hydroxyvitamin D	12 weeks

Collaborators and Investigators

• Sponsor: Technical University of Denmark
• Collaborators: Seventh Framework Programme
• Investigators: Principal Investigator: Inge Tetens, Professor, Technical University of Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: November 11, 2015
• First Submitted That Met QC Criteria: December 11, 2015
• First Posted (Estimate): December 16, 2015

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 17, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Vitamin D; Fortification
• Additional Relevant MeSH Terms: Nutrition Disorders; Avitaminosis; Deficiency Diseases; Malnutrition; Vitamin D Deficiency
• Other Study ID Numbers: H-15008276; FP7-613977-ODIN (Other Grant/Funding Number: EU FP7)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED