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Abstract Number: 1242

A Prospective Randomized Open Label Trial To Evaluate The Effect Of Food On Vitamin D Absorption

Lucas Grisanti1, Zeenat Ali2, Joseph M. Grisanti3, James Hatem4, Mary Brennan5, Michael Grisanti3, Mary Margaret O'Neil3, Linda Burns3 and Kostas Botsoglou6, 1Department of Biology, College of Wooster, Wooster, OH, 2Medicine, Mercy Hospital of Buffalo, Buffalo, NY, 3Buffalo Rheumatology, Orchard Park, NY, 4BioStatistics, Buffalo Rheumatology, Orchard Park, NY, 5Research Division, Buffalo Rheumatology, Orchard Park, NY, 6Sisters Hospital, Buffalo, NY

Meeting: 2013 ACR/ARHP Annual Meeting

Keywords: 25 OH D Vitamin insufficiency, 25-hydroxyvitamin D and Vitamin D

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Session Information

Title: Osteoporosis and Metabolic Bone Disease: Clinical Aspects and Pathogenesis

Session Type: Abstract Submissions (ACR)

Background/Purpose: Vitamin D deficiency is commonplace throughout the world and is associated with a number of health related consequences. Being a fat-soluble vitamin, speculation has emerged regarding enhanced vitamin D absorption when administered with food. Theorizing that bile salts and digestive lipases enhance vitamin D absorption, we conducted this randomized controlled clinical trial. The objective of this study was to determine if administering vitamin D with the largest meal of the day enhanced vitamin D absorption when compared to a similar group where replacement vitamin D was given following an overnight fast.

Methods: Subjects 18 years of age or greater with a low 25(OH) vitamin D level between 10 and 30 ng/mL were considered for enrollment. A total of 326 subjects were randomly assigned to a vitamin D replacement regimen that was administered either with the largest meal of the day or following an overnight fast. Four separate vitamin D replacement regimens were studied: 50,000 IU vitamin D2 once weekly, 4,000 IU vitamin D3 daily, 2,000 IU vitamin D3 daily, and 1,000 IU vitamin D daily. Results were assessed by improvement in repeat serum 25(OH) vitamin D levels obtained following 12 weeks of replacement therapy. Completers were defined as subjects who were at least 80% compliant with study medication and had a follow-up vitamin D level drawn at study completion. A total of 249 subjects completed the study.

Results: Of the 249 individuals completing the study, 118 took vitamin D with their largest meal while 131 fasted. The mean improvement in 25(OH) vitamin D levels for the “with food” group was 57% (mean baseline: 23.0, mean ending value: 36.1) with a mean raw difference of 13.2 (95% CI 11.2-15.2). Subjects in the fasting group demonstrated a mean improvement in 25(OH) vitamin D levels of 51% (mean baseline: 22.7, mean ending value: 34.2) with a mean difference of 11.5 (95% CI 9.4-13.6). While improvement in 25(OH) vitamin D levels in the entire cohort was 15% greater when administered with food, this improvement was not statistically significant (p=0.26) when compared to repletion following overnight fasting. Subset analysis of the four dosing regimens did demonstrate a statistically significant greater improvement in serum 25(OH) vitamin D levels when replacement was administered with food for the 4,000 IU dosing regimen (p=0.001). In this group the mean change when administered with food was 13.7 (CI 10.3-17.2) while the mean change when fasting was 6.9 (CI 4.6-9.1). Statistical differences were not achieved in the other three dosing regimens.

Conclusion: Administering vitamin D replacement with the largest daily meal resulted in a 15% greater improvement in serum 25(OH) vitamin D levels when compared to repletion following an overnight fast. This difference was not statistically significant. Subset analysis of various dosing regimens identified a statistically significant greater improvement when 4,000 IU of daily vitamin D was administered with the largest meal of the day. We conclude that administering vitamin D with the largest meal of the day may enhance vitamin D absorption, compared to taking it with a morning fast. The difference was modest and not statistically significant.


Disclosure:

L. Grisanti,
None;

Z. Ali,
None;

J. M. Grisanti,
None;

J. Hatem,
None;

M. Brennan,
None;

M. Grisanti,
None;

M. M. O’Neil,
None;

L. Burns,
None;

K. Botsoglou,
None.

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