Food-based Solutions for Optimal Vitamin D Nutrition and Health

Vitamin D Deficiency Clinical Trial

— ODIN_FOOD  

Official title:

Food-based Solutions for Optimal Vitamin D Nutrition and Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02631629
• Other study ID #: H-15008276
• Secondary ID: FP7-613977-ODIN
• Status: Completed
• Phase: N/A
• First received: November 11, 2015
• Last updated: October 17, 2016
• Start date: November 2015
• Est. completion date: May 2016

Study information

• Verified date: October 2016
• Source: Technical University of Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Other:
• Non-fortified foods
The non-fortified placebo foods are eggs, cheese, yoghurt and crisp bread (without vitamin D added).
• Fortified foods
The fortified intervention foods are eggs, cheese, yoghurt and crisp bread (with about 20 mcg/day).

Locations

Country	Name	City	State
Denmark	Technical University of Denmark	Søborg

Sponsors (2)

Lead Sponsor	Collaborator
Technical University of Denmark	Seventh Framework Programme

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in vitamin D status measured as serum 25-hydroxyvitamin D		12 weeks	No