Food-based Solutions for Optimal Vitamin D Nutrition and Health (ODIN_FOOD)

Technical University of Denmark

Status: Completed

Conditions: Vitamin D Deficiency

Treatments: Other: Non-fortified foods; Other: Fortified foods

Study type: Interventional

Funder types: Other

Identifiers

NCT02631629

FP7-613977-ODIN (Other Grant/Funding Number)

H-15008276

Details and patient eligibility

About

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.

Full 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.

Enrollment: 143 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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143 participants in 4 patient groups, including a placebo group

Non-fortified foods SA

Placebo Comparator group

Description:

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

Treatment:

Other: Non-fortified foods

Non-fortified foods CA

Placebo Comparator group

Description:

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

Treatment:

Other: Non-fortified foods

Vitamin D fortified foods SA

Active Comparator group

Description:

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

Treatment:

Other: Fortified foods

Vitamin D fortified foods CA

Active Comparator group

Description:

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

Treatment:

Other: Fortified foods