A Single Wintertime Dose of Vitamin D3 to Prevent Winter Decline in Vitamin D Status in Healthy Adults
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 6/4/2016 |
| Start Date: | October 2012 |
| End Date: | May 2016 |
A Single Wintertime Dose of Vitamin D3 to Prevent Winter Decline in Vitamin D Concentrations in Healthy Adults: A Pilot Study
The purpose of this study is to determine if a single dose of vitamin D administered orally
in the fall will provide adequate vitamin D in healthy individuals for the duration of the
winter, during which vitamin D levels are known to decrease. The investigators are also
interested in finding out if this level of vitamin D will provide adequate levels for the
remainder of the year. While the benefits of once-yearly vitamin D administration are clear
for patients with osteoporosis, osteomalacia, rickets, and other conditions associated with
vitamin D deficiency and high bone turn-over, studies have not been performed in which high
doses of vitamin D were used to prevent the seasonal decline of vitamin D concentrations in
healthy individuals. These findings could provide evidence to support vitamin D
administration to healthy individuals in the wintertime to improve health outcomes, and
provide the basis for additional studies in both healthy and sick populations.
in the fall will provide adequate vitamin D in healthy individuals for the duration of the
winter, during which vitamin D levels are known to decrease. The investigators are also
interested in finding out if this level of vitamin D will provide adequate levels for the
remainder of the year. While the benefits of once-yearly vitamin D administration are clear
for patients with osteoporosis, osteomalacia, rickets, and other conditions associated with
vitamin D deficiency and high bone turn-over, studies have not been performed in which high
doses of vitamin D were used to prevent the seasonal decline of vitamin D concentrations in
healthy individuals. These findings could provide evidence to support vitamin D
administration to healthy individuals in the wintertime to improve health outcomes, and
provide the basis for additional studies in both healthy and sick populations.
Vitamin D, synthesized from 7-dehydrocholesterol during ultraviolet- B exposure, aids in the
absorption of calcium from the G.I. tract. Indirectly, by maintaining optimal calcium
homeostasis, adequate vitamin D concentrations are essential in skeletal health (by
preventing rickets and osteomalacia), cardiovascular health (by lowering the risk for
hypertension), and ultimately decreasing mortality. Due to decreased direct sunlight
exposures in the winter (characterized by limited outdoor activity, increased clothing
coverage, and angle of the sun), vitamin D concentrations are shown to decline in
individuals over the winter. Once-yearly administration of a bolus of vitamin D offers a
means of preventing the seasonal decline in vitamin D status and preventing vitamin D
deficiency. If proven successful, a once-yearly dose of vitamin D would provide improved
compliance relative to daily or monthly dosing and provide an inexpensive and easy way to
ensure optimal concentrations of vitamin D year-round.
This pilot study plans to investigate if once a year dosing with vitamin D during the winter
months in self-identified healthy adults will be effective in maintaining optimal vitamin D
status for the entire year. In brief, this study will be a randomized, double blind,
placebo-controlled study to evaluate the efficacy of 250,000 IU of vitamin D3 compared to
placebo given once in 30 healthy individuals (15 subjects per arm) in November. The serum
25(OH)D (the best measurable level of vitamin D status) will be measured after both 3-4
months and 1 year to determine the efficacy of the dose relative to the 15 healthy controls.
The intent of this clinical investigation is not to evaluate the dietary supplement's
ability to diagnose, cure, mitigate or prevent disease. This study is to evaluate blood
concentrations of this regimen of vitamin D.
Ultimately, this study hopes to determine if a single dose of vitamin D administered orally
in the fall will provide adequate vitamin D in healthy young individuals for the 3 months
during winter, during which vitamin D levels are known to decrease, and over the entire
year. These findings could provide evidence to support vitamin D administration to healthy
individuals in wintertime to improve health outcomes, and provide the basis for additional
studies in both healthy and sick populations.
Secondary outcomes of this study will evaluate other hypothesized effects of vitamin D on
biomarkers affecting health status and immunity, including markers of inflammation and
markers of iron status.
absorption of calcium from the G.I. tract. Indirectly, by maintaining optimal calcium
homeostasis, adequate vitamin D concentrations are essential in skeletal health (by
preventing rickets and osteomalacia), cardiovascular health (by lowering the risk for
hypertension), and ultimately decreasing mortality. Due to decreased direct sunlight
exposures in the winter (characterized by limited outdoor activity, increased clothing
coverage, and angle of the sun), vitamin D concentrations are shown to decline in
individuals over the winter. Once-yearly administration of a bolus of vitamin D offers a
means of preventing the seasonal decline in vitamin D status and preventing vitamin D
deficiency. If proven successful, a once-yearly dose of vitamin D would provide improved
compliance relative to daily or monthly dosing and provide an inexpensive and easy way to
ensure optimal concentrations of vitamin D year-round.
This pilot study plans to investigate if once a year dosing with vitamin D during the winter
months in self-identified healthy adults will be effective in maintaining optimal vitamin D
status for the entire year. In brief, this study will be a randomized, double blind,
placebo-controlled study to evaluate the efficacy of 250,000 IU of vitamin D3 compared to
placebo given once in 30 healthy individuals (15 subjects per arm) in November. The serum
25(OH)D (the best measurable level of vitamin D status) will be measured after both 3-4
months and 1 year to determine the efficacy of the dose relative to the 15 healthy controls.
The intent of this clinical investigation is not to evaluate the dietary supplement's
ability to diagnose, cure, mitigate or prevent disease. This study is to evaluate blood
concentrations of this regimen of vitamin D.
Ultimately, this study hopes to determine if a single dose of vitamin D administered orally
in the fall will provide adequate vitamin D in healthy young individuals for the 3 months
during winter, during which vitamin D levels are known to decrease, and over the entire
year. These findings could provide evidence to support vitamin D administration to healthy
individuals in wintertime to improve health outcomes, and provide the basis for additional
studies in both healthy and sick populations.
Secondary outcomes of this study will evaluate other hypothesized effects of vitamin D on
biomarkers affecting health status and immunity, including markers of inflammation and
markers of iron status.
Inclusion Criteria:
1. Healthy adult (by self-report) between ages 18-65
Exclusion Criteria:
1. reported granulomatous conditions
2. history of kidney disease (renal failure, renal stones, serum creatinine over 0.06
ng/mL in the past)
3. diabetes
4. currently taking anticonvulsants, barbituates, antihypertensives, steroids of any
form, or drugs that effect bone metabolism
5. history of calcium or bone abnormalities (including osteoporosis)
6. primary hyperparathyroidism
7. thyrotoxicosis
8. Paget's disease
9. history of malignancy
10. known liver disease
11. calcium supplements >1000 mg/day
12. complete immobilization
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