Serum 25-hydroxyvitamin D Concentrations (25OHD) Clinical Trial
— BreaD_ODINOfficial title:
Work Package 5: The Potential Advantages and Limitations of Use of Novel Food-based Solutions for Prevention of Vitamin D Deficiency. Food-based Solutions for Optimal Vitamin D Nutrition and Health Through the Life Cycle (ODIN)
Verified date | August 2015 |
Source | Helsinki University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Finland: Ethics Committee |
Study type | Interventional |
Vitamin D3 is synthesized in skin exposed to ultraviolet-B-irradiation of sunlight. However, in Northern Europe, including Finland, exposure to sunlight is limited or non-existent in winter. Between November and March, dietary or supplementary vitamin D intake is essential to maintain adequate serum 25-hydroxyvitamin D (S-25(OH)D) concentrations. There are only a few natural dietary sources of vitamin D. Fish and egg yolks contain significant amounts of vitamin D3 (cholecalciferol), and some wild mushrooms are a source of vitamin D2 (ergocalciferol). Thus, vitamin D fortification of certain foods has been accepted as one strategy to improve vitamin D status of these populations. Vitamin D3 is currently mostly used in fortified products in Europe, although the production of plant-derived vitamin D2 would be more cost-effective. Data on the impact of food-derived vitamin D2 on S-25(OH)D3 are limited. An important consideration is whether food-based sources of vitamin D2 are effective in raising S-25(OH)D or whether they have a negative impact on S-25(OH)D3. The investigators investigated the bioavailability of vitamin D2 from UVB-radiated baking yeast in bread in terms of efficacy of raising total S-25(OH)D) as well its possible effects on S-25(OH)D2, S-25(OH)D3, serum parathyroid hormone (S-PTH) and serum calcium concentrations compared with D2 and D3 supplementation in a randomized placebo-controlled trial in young healthy females during winter in Finland.
Status | Completed |
Enrollment | 41 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 40 Years |
Eligibility |
Inclusion Criteria: - good general health (no continuous medication), - Caucasian origin, - body mass index (BMI) <30 kg/m2 - age 20-40 years Exclusion Criteria: - diagnosed celiac disease or cereal allergy - a vacation in a sunny place during the study or within the preceding 2 months - regular use of vitamin D supplements >15 µg/d - pregnancy or breastfeeding during the study |
Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Finland | Department of Food and Environmental Sciences, University of Helsinki | Helsinki |
Lead Sponsor | Collaborator |
---|---|
Helsinki University | Technical University of Denmark, University College Cork |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum total 25-hydroxyvitamin D (25(OH)D) | The effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum 25(OH)D concentration | Change from baseline in total 25(OH)D concentration at 4 and 8 weeks | No |
Secondary | Serum parathyroid hormone (PTH) concentration | The effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum PTH concentration | Change from baseline in serum PTH concentration at 4 and 8 weeks | No |
Secondary | Serum calcium concentration | The effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum calcium concentration | Change from baseline in serum calcium concentration at 4 and 8 weeks | No |
Secondary | Serum 25-hydroxyvitamin D2 (25(OH)D2) | The effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum 25(OH)D2 concentration | Change from baseline in 25(OH)D2 concentration at 4 and 8 weeks | No |
Secondary | Serum 25-hydroxyvitamin D3 (25(OH)D3) | The effect of vitamin D (as form of D3, D2 or D2-fortified bread )supplementation on the serum 25(OH)D3 concentration | Change from baseline in 25(OH)D3 concentration at 4 and 8 weeks | No |
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