NCT00204919

Brief Summary

Administration of vitamin D 50,000 units once monthly will:

  • Maintain serum 25-OH vitamin D above 20 ng/ml
  • Reduce falls
  • Increase calcaneal BMD
  • Reduce bone turnover
  • Be well tolerated: volunteers will not develop hypercalcemia
  • Improve performance on a swallowing quality of life questionnaire

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2001

Longer than P75 for not_applicable

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

June 1, 2001

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

October 4, 2023

Status Verified

September 1, 2015

Enrollment Period

2.9 years

First QC Date

September 13, 2005

Last Update Submit

October 2, 2023

Conditions

Vitamin D DeficiencyOsteoporosis

Keywords

osteoporosisvitamin D deficiency

Outcome Measures

Primary Outcomes (1)

  • Plasma 25-hydroxyvitamin D levels

    1 year

Secondary Outcomes (1)

  • Plasma calcium

    one year

Study Arms (2)

1

PLACEBO COMPARATOR
Drug: placebo

2

ACTIVE COMPARATOR
Drug: Vitamin D

Interventions

Vitamin DDRUG

once-monthly vitamin D oral capsules (50,000 units)

Also known as: ergocalciferol
2
placeboDRUG

once-monthly placebo capsules

Also known as: lactose
1

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female
  • Nursing Home Resident in Wisconsin

You may not qualify if:

  • Renal Failure
  • Hypercalcemia
  • Metastatic Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Vitamin D DeficiencyOsteoporosis

Interventions

Vitamin DErgocalciferolsLactose

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCholestenesCholestanesSterolsMembrane LipidsLipidsDisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Mary Elliott, PharmD, PhD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

June 1, 2001

Primary Completion

May 1, 2004

Study Completion

November 1, 2004

Last Updated

October 4, 2023

Record last verified: 2015-09

Locations

US(1)