The BreaD Study - Bio-availability of D2 Vitamin Present in Bread

Serum 25-hydroxyvitamin D Concentrations (25OHD) Clinical Trial

— BreaD_ODIN  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02525003
• Other study ID #: HelsinkiUni
• Status: Completed
• Phase: N/A
• First received: August 10, 2015
• Last updated: August 13, 2015
• Start date: January 2014
• Est. completion date: April 2014

Study information

• Verified date: August 2015
• Source: Helsinki University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Serum 25-hydroxyvitamin D Concentrations (25OHD)

Intervention

Dietary Supplement:
• Vitamin D2
Experimental group 2: daily vitamin D2 supplement 25ug/d for 8 weeks
• Vitamin D3
Experimental group 3: daily vitamin D3 supplement 25ug/d for 8 weeks

Other:
• Vitamin D2 fortified bread
Experimental group 4: vitamin D2 fortified bread containing 25 µg of vitamin D2/d (bread dose 87g/d) and placebo pill for 8 weeks

Locations

Country	Name	City	State
Finland	Department of Food and Environmental Sciences, University of Helsinki	Helsinki

Sponsors (3)

Lead Sponsor	Collaborator
Helsinki University	Technical University of Denmark, University College Cork

Country where clinical trial is conducted

Finland, 

Outcome

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