Food-based Solutions for Optimal Vitamin D Nutrition and Health

Study Overview
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Brief Summary
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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
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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.

Official Title
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Food-based Solutions for Optimal Vitamin D Nutrition and Health

Conditions
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Vitamin D Deficiency

Intervention / Treatment
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* Other: Non-fortified foods
* Other: Fortified foods


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Fortification