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An Open‐label Study to Evaluate the Effect of 5,000 IU of Vitamin D3 Softgel on Serum 25‐hydroxyvitamin D Levels among Healthy Adults
Author(s) -
Hirsh Steven,
Huber Luke,
Schmid Kira,
Woolger Judith,
Joyal Steven
Publication year - 2015
Publication title -
the faseb journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.709
H-Index - 277
eISSN - 1530-6860
pISSN - 0892-6638
DOI - 10.1096/fasebj.29.1_supplement.606.9
Subject(s) - bioavailability , vitamin d and neurology , medicine , vitamin , ingestion , adverse effect , cholecalciferol , physiology , gastroenterology , pharmacology
Background There has been little research performed to determine the most effective vehicle, from a bioavailability perspective, for vitamin D supplementation. It has been observed that further studies are needed to compare the bioavailability from the use of different vehicles (eg, powders, oils, and ethanol). Objective To assess the effect of a 5,000 IU vitamin D3 lipid‐based softgel formulation on serum 25‐hydroxyvitamin D levels in healthy male and female subjects already taking a daily 5,000 IU vitamin D3 encapsulated powder formulation for at least 3 months. Methods After discontinuing their vitamin D3 capsules, 16 qualified participants were dispensed and instructed to take a lipid‐based softgel formulation containing 5,000 IU vitamin D3 for 60 days. Assessments of 25‐hydroxyvitamin D level were conducted at baseline (prior to vitamin D3 softgel ingestion), Day 30, and Day 60. Results Fifteen participants completed the study with no serious adverse events reported. 25‐hydroxyvitamin D levels increased an average of 7.34 ng/mL (16%) by day 30 and 13.1 ng/mL (28.5%) by day 60 compared to baseline. The mean changes from baseline to days 30 and 60 were statistically significant. Conclusion The lipid‐based softgel formulation containing 5,000 IU of vitamin D3 taken daily for 60 days was associated with a statistically significant increase in 25‐hydroxyvitamin D levels among healthy adults subsequent to use of 5,000 IU vitamin D3 capsules for 3 months or more. Hence, our findings provide a rationale for further studies investigating the most effective vehicle for vitamin D3 supplementation.