Vitamin D deficiency is common. It is caused by limited sun availability together with a low supply of vitamin D in the food system. There is a high prevalence of low vitamin D status around the world. In Ireland, our relatively northern latitude and prevailing weather mean that UVB availability for skin synthesis of vitamin D is limited in this country and our population relies on the dietary supply of vitamin D to prevent deficiency. Thus, the endemic Irish problem of vitamin D malnutrition is due to the lack of vitamin D in our food system. Dietary guidelines cannot address this issue because foods naturally rich in vitamin D are very few and infrequently consumed. The OASIS study will test the hypothesis that a vitamin D-fortified bread as part of a healthy diet that includes vitamin D-fortified foods is effective in preventing low vitamin D status during winter, and safe for older adults to consume.
This randomised controlled dietary intervention study aims to recruit 200 older adults (\>65 years) who will be randomised to receive vitamin D-fortified bread and advice to consume additional commercially available fortified foods (Treatment group) or identical unfortified bread and advice to consume additional commercially available fortified foods (Control group). The outcome of the study is to test whether increasing vitamin D intake through food (Treatment group) is sufficient to prevent wintertime vitamin D deficiency (measured using serum concentrations of 25-hydroxyvitamin D \<30 nmol/L) in comparison with the Control group. The target vitamin D intake for the treatment group in this study is \>15-20 μg/day vitamin D. This will maintain serum concentrations of 25-hydroxyvitamin D (25(OH)D) (the biomarker of vitamin D status) \> 30 nmol/L, the clinical deficiency threshold to prevent metabolic bone disease, in over 90% of participants. At this vitamin D intake level, about 80% of participants will have a 25(OH)D concentration \> 50 nmol/L, the personal intake target in the US and EU.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
117
Intervention group will be supplied with fortified bread delivering 10 -15 μg (400-600 IU) vitamin D3 in a daily portion and will receive dietary advice to incorporate fortified foods that are commonly available on the market in their diet.
Placebo control group will be supplied with unfortified bread and will receive dietary advice to incorporate fortified foods that are commonly available on the market in their diet.
Human Nutrition Studies Unit, School of Food and Nutritional Sciences
Cork, Cork, Ireland
UCD Institute of Food and Health
Dublin, Dublin, Ireland
Serum concentrations of 25-hydroxyvitamin D (25(OH)D)
Comparison of the number of participants with low vitamin D status (e.g. \<30 nmol/L and \< 50 nmol/L serum 25(OH)D) between treatment and placebo groups
Time frame: 10 weeks
Vitamin D intakes
Comparison of prevalence of inadequate vitamin D intakes relative to North American and European dietary recommendations
Time frame: 10 weeks
Serum concentrations of albumin-corrected serum calcium concentrations as a safety measure
Comparison of albumin-corrected serum calcium concentrations \< 2.6 mmol/L between treatment and placebo control groups
Time frame: 10 weeks
Circulating biomarkers of metabolic health status
Comparison of circulating biomarkers of metabolic health status and metabolomic markers between active and placebo groups
Time frame: 10 weeks
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