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Completed

NCT Number: NCT02631629

Food-based Solutions for Optimal Vitamin D Nutrition and Health

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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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Technical University of Denmark

Søborg, 2860, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Non-fortified foods

Other

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

Fortified foods

Other

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

Primary outcomes

  1. The change in vitamin D status measured as serum 25-hydroxyvitamin D

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Technical University of Denmark

Other

Collaborators

  • Seventh Framework Programme

Registry information

Acronym: ODIN_FOOD

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 16, 2015
Registry last updated
Oct 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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