NCT01924910

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 12, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 19, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

1.2 years

First QC Date

August 12, 2013

Last Update Submit

July 11, 2017

Conditions

Vitamin D Deficiency

Keywords

Healthy, by self report

Outcome Measures

Primary Outcomes (1)

  • blood levels of 25(OH)D

    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.

    3 months

Secondary Outcomes (4)

  • Blood Calcium level

    10 days

  • Blood pro-inflammatory cytokines

    baseline, 10 days, 3 months, 1 year

  • Blood hepcidin concentration

    baseline, 10 days

  • Blood markers of iron status

    baseline, 10 days

Study Arms (2)

Placebo Pill

PLACEBO COMPARATOR

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

Vitamin D

ACTIVE COMPARATOR

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

Interventions

250,000 IU cholecalciferol as single, oral doseDIETARY_SUPPLEMENT

250,000 IU cholecalciferol (vitamin D3) provided as a single oral dose.

Also known as: vitamin D3
Vitamin D
PlaceboDIETARY_SUPPLEMENT
Placebo Pill

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Healthy adult (by self-report) between ages 18-65

You may not qualify if:

  • reported granulomatous conditions
  • history of kidney disease (renal failure, renal stones, serum creatinine over 0.06 ng/mL in the past)
  • diabetes
  • currently taking anticonvulsants, barbituates, antihypertensives, steroids of any form, or drugs that effect bone metabolism
  • history of calcium or bone abnormalities (including osteoporosis)
  • primary hyperparathyroidism
  • thyrotoxicosis
  • Paget's disease
  • history of malignancy
  • known liver disease
  • calcium supplements \>1000 mg/day
  • complete immobilization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Campus

Atlanta, Georgia, 30322, United States

Location

Related Publications (1)

  • Kearns MD, Binongo JN, Watson D, Alvarez JA, Lodin D, Ziegler TR, Tangpricha V. The effect of a single, large bolus of vitamin D in healthy adults over the winter and following year: a randomized, double-blind, placebo-controlled trial. Eur J Clin Nutr. 2015 Feb;69(2):193-7. doi: 10.1038/ejcn.2014.209. Epub 2014 Oct 1.

    PMID: 25271011DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

CholecalciferolSingle Person

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipidsMarital StatusFamily CharacteristicsDemographyPopulation CharacteristicsSocioeconomic Factors

Study Officials

  • Vin Tangpricha, MD, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 12, 2013

First Posted

August 19, 2013

Study Start

October 1, 2012

Primary Completion

December 1, 2013

Study Completion

July 1, 2017

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

US(1)