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A Single Wintertime Dose of Vitamin D3 to Prevent Winter Decline in Vitamin D Status in Healthy Adults

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ClinicalTrials.gov Identifier: NCT01924910
Recruitment Status : Completed
First Posted : August 19, 2013
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Vin Tangpricha, MD, PH.D, Emory University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: 250,000 IU cholecalciferol as single, oral dose Dietary Supplement: Placebo Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single Wintertime Dose of Vitamin D3 to Prevent Winter Decline in Vitamin D Concentrations in Healthy Adults: A Pilot Study
Study Start Date : October 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Pill
Received identical pills that do not contain vitamin D. Blood levels of 25(OH)D determined at 10 days, 3 months, and 1 year following placebo dose.
Dietary Supplement: Placebo
Active Comparator: Vitamin D
250,000 IU cholecalciferol as single, oral dose. Blood levels 25(OH)D measured at 10 days, 3 months, and 1 year following dose.
Dietary Supplement: 250,000 IU cholecalciferol as single, oral dose
250,000 IU cholecalciferol (vitamin D3) provided as a single oral dose.
Other Name: vitamin D3




Primary Outcome Measures :
  1. blood levels of 25(OH)D [ Time Frame: 3 months ]
    Measure blood levels of 25(OH)D, an indicator of vitamin D status, at 10 days, 3 months, and 1 year following vitamin D or placebo dose.


Secondary Outcome Measures :
  1. Blood Calcium level [ Time Frame: 10 days ]
    Measured blood calcium levels at 10 days following dose. This measure assessed safety of large vitamin D dose regarding its potential to cause hypercalcemia.

  2. Blood pro-inflammatory cytokines [ Time Frame: baseline, 10 days, 3 months, 1 year ]
    Measured blood cytokine (IL-6, IL-1B, IL-8, MCP-1) concentrations at baseline, 10 days, 3 months, and 1 year

  3. Blood hepcidin concentration [ Time Frame: baseline, 10 days ]
    Measured blood hepcidin concentrations at baseline and 10 days

  4. Blood markers of iron status [ Time Frame: baseline, 10 days ]
    Measured blood ferritin concentrations at baseline and 10 days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924910


Locations
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United States, Georgia
Emory University Campus
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
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Principal Investigator: Vin Tangpricha, MD, PhD Emory University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vin Tangpricha, MD, PH.D, Professor, Emory University
ClinicalTrials.gov Identifier: NCT01924910     History of Changes
Other Study ID Numbers: IRB00061103
OnceYearlyD ( Other Identifier: Other )
First Posted: August 19, 2013    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017

Keywords provided by Vin Tangpricha, MD, PH.D, Emory University:
Healthy, by self report

Additional relevant MeSH terms:
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Vitamins
Vitamin D
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents