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| ID | Type | Description | Link |
|---|---|---|---|
| FP7-613977-ODIN | Other Grant/Funding Number | EU FP7 |
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| Name | Class |
|---|---|
| Seventh Framework Programme | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-fortified foods SA | Placebo Comparator | Non-fortified foods (eggs, cheese, yoghurt, crips bread) (placebo), women of South Asian (SA) origin |
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| Non-fortified foods CA | Placebo Comparator | Non-fortified foods (eggs, cheese, yoghurt, crips bread) (placebo), women of Caucasian (CA) origin |
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| Vitamin D fortified foods SA | Active Comparator | Vitamin D fortified foods (eggs, cheese, yoghurt, crips bread), women of South Asian (SA) origin |
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| Vitamin D fortified foods CA | Active Comparator | Vitamin D fortified foods (eggs, cheese, yoghurt, crips bread), women of Caucasian (CA) origin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-fortified foods | Other | The non-fortified placebo foods are eggs, cheese, yoghurt and crisp bread (without vitamin D added). |
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| Measure | Description | Time Frame |
|---|---|---|
| The change in vitamin D status measured as serum 25-hydroxyvitamin D | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Inge Tetens, Professor | Technical University of Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Technical University of Denmark | Søborg | 2860 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30852657 | Derived | Gronborg IM, Tetens I, Christensen T, Andersen EW, Jakobsen J, Kiely M, Cashman KD, Andersen R. Vitamin D-fortified foods improve wintertime vitamin D status in women of Danish and Pakistani origin living in Denmark: a randomized controlled trial. Eur J Nutr. 2020 Mar;59(2):741-753. doi: 10.1007/s00394-019-01941-6. Epub 2019 Mar 9. |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D005527 | Food, Fortified |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Fortified foods | Other | The fortified intervention foods are eggs, cheese, yoghurt and crisp bread (with about 20 mcg/day). |
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| D009750 |
| Nutritional and Metabolic Diseases |