Food-based Solutions for Optimal Vitamin D Nutrition and Health

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02631629

Acronym

ODIN_FOOD

Enrollment

143

Registered

2015-12-16

Start date

2015-11-30

Completion date

2016-05-31

Last updated

2016-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

Keywords

Vitamin D, Fortification

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.

Interventions

OTHERNon-fortified foods

The non-fortified placebo foods are eggs, cheese, yoghurt and crisp bread (without vitamin D added).

OTHERFortified foods

The fortified intervention foods are eggs, cheese, yoghurt and crisp bread (with about 20 mcg/day).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026