Food-based Solutions for Optimal Vitamin D Nutrition and Health

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-05-31

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.

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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.

Conditions

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Vitamin D Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Non-fortified foods SA

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

Group Type PLACEBO_COMPARATOR

Non-fortified foods

Intervention Type OTHER

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

Non-fortified foods CA

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

Group Type PLACEBO_COMPARATOR

Non-fortified foods

Intervention Type OTHER

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

Vitamin D fortified foods SA

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

Group Type ACTIVE_COMPARATOR

Fortified foods

Intervention Type OTHER

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

Vitamin D fortified foods CA

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

Group Type ACTIVE_COMPARATOR

Fortified foods

Intervention Type OTHER

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

Interventions

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Non-fortified foods

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

Intervention Type OTHER

Fortified foods

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

Intervention Type OTHER

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes