NCT00986596

Brief Summary

The purpose of the study is to investigate the effect of vitamin D on muscle tissue and physical performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2006

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

October 1, 2006

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

January 10, 2012

Status Verified

January 1, 2012

Enrollment Period

4.3 years

First QC Date

September 29, 2009

Last Update Submit

January 6, 2012

Conditions

SarcopeniaFalls

Keywords

vitamin Dskeletal musclevitamin D receptor

Outcome Measures

Primary Outcomes (1)

  • Define and compare changes in size and number of type II muscle fibers in response to 4 months of treatment with 4000 IU of vitamin D3 per day or placebo in older women with low-normal 25(OH)D levels.

    4 months

Secondary Outcomes (3)

  • Define and compare vitamin D signaling in muscle biopsy specimens taken before and after the treatment.

    4 months

  • Define and compare changes in clinical measures of muscle performance before and after treatment

    4 months

  • Define and compare levels of bone turnover before and after treatment

    4 months

Study Arms (2)

vitamin D3

ACTIVE COMPARATOR

vitamin D3 capsule 4000 IU p.o. daily

Dietary Supplement: vitamin D3

placebo

PLACEBO COMPARATOR

microcrystalline cellulose capsule p.o. daily (identical to vitamin D capsule)

Dietary Supplement: Placebo

Interventions

vitamin D3DIETARY_SUPPLEMENT

4000 IU once daily by mouth for 4 months

vitamin D3
PlaceboDIETARY_SUPPLEMENT

microcrystalline cellulose capsule p.o. daily (identical to vitamin D capsule)

placebo

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age 65 and older
  • (OH)D levels \>22.5 nmol/l or \<60 nmol/l
  • Women must have a composite physical performance score of ≤ 9 out of a possible score of 12.
  • Subjects must agree not to change their usual level of physical activity or change the amount of calcium and vitamin D supplement they use for the duration of the study.
  • If they are taking calcium supplements, they must agree to take the supplement any time after lunch.

You may not qualify if:

  • General:
  • Total calcium intake \>1000mg daily on the prescreening questionnaire.
  • More than 400 IU daily of supplemental vitamin D on the prescreening questionnaire.
  • A screening 25(OH)D level \> 60 nmol/ L.
  • Screening 24-hour urine calcium \> 275 mg.
  • An abnormal serum calcium.
  • Travel to latitude \<35 degrees N within 2 months of the time of enrollment; plans to travel to latitude \<35 degrees N during the 4-month study, with the likelihood of tanning (e.g. appreciable sun exposure without sun screen).
  • Greater than 2 drinks of alcohol a day.
  • Medications:
  • Bone active drugs such as bisphosphonates, estrogen, calcitonin, teriparatide
  • Diuretics
  • Oral glucocorticoids in the last month
  • Phosphates in the last week
  • Lithium
  • Cod liver oil
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Bess Dawson-Hughes, MD

    Tufts University

    PRINCIPAL INVESTIGATOR

  • Lisa Ceglia, MD

    Tufts University

    STUDY DIRECTOR

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
PRINCIPAL INVESTIGATOR
PI Title
Director, Bone Metabolism Laboratory

Study Record Dates

First Submitted

September 29, 2009

First Posted

September 30, 2009

Study Start

October 1, 2006

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

January 10, 2012

Record last verified: 2012-01

Locations

US(1)