The Effect of a Meal on Vitamin D Absorption



Status:Archived
Conditions:Other Indications, Gastrointestinal
Therapuetic Areas:Gastroenterology, Other
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:December 2010
End Date:June 2012

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Meal Effects on the 25OHD3 Response to Supplemental Vitamin D3


This study seeks to determine if vitamin D3 absorption in healthy adults will be enhanced in
the presence of a meal and if the enhancement will be greater when the meal is low as
opposed to high in fat content. The enhancement will result from increased vitamin D
absorption. The investigators will test this hypothesis by pursuing the following aims in a
3-mo trial in which up to 70 healthy men and women will be randomized to one of the
following meal conditions under which they will take a monthly oral dose of 50,000 IU of
vitamin D3: no meal (fasting), a low fat meal, or a high fat meal. The Primary Aim is to
identify the meal condition (fasting, low-fat, or high-fat meal) under which the 25OHD3
response to supplemental vitamin D3 is greatest and most consistent. The Secondary Aim is to
determine whether vitamin D3 absorption is affected by the meal condition and to determine
whether the absorption of vitamin D3 predicts the longer-term 25OHD3 response to
supplementation.


Vitamin D supplements are increasingly recommended to curb widespread deficiency. Decreasing
the variability in 25OHD responses to supplemental vitamin D would make the supplementation
process more predictable, and thereby reduce the number of 25OHD measurements and dose
adjustments that are needed to achieve the targeted 25OHD level. This study seeks to
identify potential sources of variability in the 25OHD3 response to supplemental vitamin D3
that are plausible based on rat studies, but have not been explored in humans. The
investigators hypothesize that the serum 25OHD3 response to supplemental vitamin D3 in
healthy adults will be enhanced in the presence of a meal and the enhancement will be
greater when the meal is low as opposed to high in fat content. The enhancement will result
from increased vitamin D absorption. The investigators will test this hypothesis by pursuing
the following aims in a 3-mo trial in which up to 70 healthy men and women will be
randomized to one of the following meal conditions under which they will take a monthly oral
dose of 50,000 IU of vitamin D3: no meal (fasting), a low fat meal, or an iso-caloric high
fat meal. Serum 25OHD3 will be measured at baseline and after 1 and 3 mo. A serum vitamin
D3 absorption test will be performed in each subject after the first dose of vitamin D. The
Primary Aim is to identify the meal condition (fasting, low-fat, or high-fat meal) under
which the 25OHD3 response to supplemental vitamin D3 is greatest and most consistent. The
Secondary Aim is to determine whether vitamin D3 absorption is affected by the meal
condition and to determine whether the absorption of vitamin D3 predicts the longer-term
25OHD3 response to supplementation.


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