Food-based Solutions for Optimal Vitamin D Nutrition and Health
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 143
- Locations
- 2
- Primary Endpoint
- The change in vitamin D status measured as serum 25-hydroxyvitamin D
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts 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).
Outcomes
Primary Outcomes
The change in vitamin D status measured as serum 25-hydroxyvitamin D
Time Frame: 12 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Inge Tetens
Professor
Technical University of Denmark