Food-based Solutions for Optimal Vitamin D Nutrition and Health

Not Applicable

Completed

• Conditions: Vitamin D Deficiency
• Interventions: Other: Non-fortified foods; Other: Fortified foods

• Registration Number: NCT02631629
• Lead Sponsor: Technical University of Denmark

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-11
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-16
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 143

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-fortified foods CA	Non-fortified foods	Non-fortified foods (eggs, cheese, yoghurt, crips bread) (placebo), women of Caucasian (CA) origin
Vitamin D fortified foods SA	Fortified foods	Vitamin D fortified foods (eggs, cheese, yoghurt, crips bread), women of South Asian (SA) origin
Vitamin D fortified foods CA	Fortified foods	Vitamin D fortified foods (eggs, cheese, yoghurt, crips bread), women of Caucasian (CA) origin
Non-fortified foods SA	Non-fortified foods	Non-fortified foods (eggs, cheese, yoghurt, crips bread) (placebo), women of South Asian (SA) origin

Primary Outcome Measures

Name	Time	Method
The change in vitamin D status measured as serum 25-hydroxyvitamin D	12 weeks

Trial Locations

Locations (1)

Technical University of Denmark; 🇩🇰 Søborg, Denmark