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Long-term effects of giving nursing home residents bread fortified with 125 µg (5000 IU) vitamin D₃ per daily serving

¹ From the Departments of Pathophysiology (VM and VL), Endocrinology (ARC and EZ), and Hygiene (OV), University of Medicine and Pharmacy Iasi, Iasi Romania; the Nutritional Resource Foundation, WI (PAS); and the Departments of Nutritional Sciences, Laboratory Medicine, and Pathobiology, University of Toronto, Mount Sinai Hospital, Toronto, Canada (RV).

² This publication is dedicated to the memory of Paul Stitt, who died shortly before the publication of this research that he made possible.

³ Supported by Natural Ovens of Manitowoc, Manitowoc, WI.

⁴ Reprints not available. Address correspondence to V Mocanu (Department of Pathophysiology, University of Medicin and Pharmacy Iasi "Gr T Popa," 16, Universitatii, 700115 Iasi, Romania. E-mail: vmocanu{at}iasi.mednet.ro) or to R Vieth (Departments of Nutritional Sciences, Laboratory Medicine, and Pathobiology, Bone and Mineral Laboratory, Pathology and Laboratory Medicine, Mount Sinai Hospital, 600 University Avenue, Toronto, Ontario, Canada, M5G 1X5. E-mail: rvieth{at}mtsinai.on.ca).

Background: In older adults, a serum 25-hydroxyvitamin D [25(OH)D] concentration >75 nmol/L lowers the risk of fracture. An oral intake of 125 µg (5000 IU) vitamin D₃/d may be required to achieve this target.

Objective: The objective was to characterize the safety and efficacy of fortifying bread with a biologically meaningful amount of vitamin D₃.

Design: In a single-arm design, 45 nursing home residents consumed one bun daily that had been fortified with 125 µg (5000 IU) vitamin D₃ and 320 mg elemental calcium.

Results: The initial mean (±SD) serum 25(OH)D concentration was 28.5 ± 10.8 nmol/L. After 12 mo, the 25(OH)D concentration was 125.6 ± 38.8 nmol/L, and it exceeded 74 nmol/L in 92% of the patients. At every 3-mo follow-up, serum parathyroid hormone was lower than at baseline (P = 0.001). No changes in serum calcium or cases of hypercalcemia were observed at the follow-up assessments. Both mean total urinary calcium and the mean urinary calcium-creatinine ratio increased from baseline at one follow-up time point (P < 0.05). Between baseline and the 12-mo visit, z scores for bone mineral density at the lumbar spine and the hip both increased significantly (P < 0.001).

Conclusions: Fortification of bread with much more vitamin D than used previously produced no evident adverse effects on sun-deprived nursing home residents and improved bone density measures. Fortification of bread with 5000 IU vitamin D₃/d provided reasonable assurance that vitamin D–deficient older adults attained a serum 25(OH)D concentration greater than the desirable objective of >75 nmol/L. This trial was registered at clinicaltrials.gov as NCT00789503.

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