NCT00933244

Brief Summary

The purpose of this study is to answer the following questions: Does vitamin D increase calcium absorption, bone mass and muscle mass and function in women past menopause who have mildly low vitamin D levels? Do these benefits require prescription-strength vitamin D, or is an over the counter vitamin D dose enough?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
230

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2010

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

First Submitted

Initial submission to the registry

July 2, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2009

Completed
9 months until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

November 10, 2015

Completed
Last Updated

November 10, 2015

Status Verified

October 1, 2015

Enrollment Period

4.3 years

First QC Date

July 2, 2009

Results QC Date

June 16, 2015

Last Update Submit

October 6, 2015

Conditions

Vitamin D Deficiency

Keywords

Vitamin DCholecalciferolParathyroid HormoneCalcium AbsorptionBone Mineral DensityMuscle Function

Outcome Measures

Primary Outcomes (1)

  • Intestinal Calcium Absorption

    Percent of calcium absorbed in the intestinal tract within one day

    One Year

Secondary Outcomes (1)

  • Bone Mineral Density

    1 Year

Other Outcomes (2)

  • Bone Turnover

    0, 30, 60, 120, 365 days

  • Muscle Function: One Year Change in Timed Up and Go Test, Five Sit-to-Stand Test

    1 Year

Study Arms (3)

High Dose Vitamin D3

OTHER

Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days. Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.

Dietary Supplement: High Dose Vitamin D3

Low Dose Vitamin D3

OTHER

Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days. Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.

Dietary Supplement: Low Dose Vitamin D3

Placebo

PLACEBO COMPARATOR

Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days. Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.

Dietary Supplement: Placebo

Interventions

High Dose Vitamin D3DIETARY_SUPPLEMENT

Yellow gel-cap vitamin D3 at 50,000 International Units daily for 15 days then two times a month for 350 days. Daily white placebo pills.

Also known as: Vitamin D, Cholecalciferol
High Dose Vitamin D3
Low Dose Vitamin D3DIETARY_SUPPLEMENT

White gel-cap vitamin D3 at 800 International Units to take orally, daily for 365 days. Intermittent yellow placebo pills.

Also known as: Vitamin D, Cholecalciferol
Low Dose Vitamin D3
PlaceboDIETARY_SUPPLEMENT

Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days. White gel-cap placebo pills once daily for 365 days.

Also known as: sugar pill
Placebo

Eligibility Criteria

AgeUp to 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Vitamin D insufficiency, defined as a serum 25(OH)D 16 to 25 ng/mL by high performance liquid chromotography assay
  • Women ≥ 5 years past the date of last menses or bilateral oophorectomy, or ≥ 60 years old if they had prior hysterectomy without bilateral oophorectomy
  • Total dietary and supplemental calcium intake \< 600 mg daily but ≤ 1,400 mg daily, based on a food frequency questionnaire

You may not qualify if:

  • Women \> 75 years old
  • Hypercalcemia (serum calcium corrected for albumin \> 10.4 mg/dL)
  • Nephrolithiasis by medical record or patient report
  • Inflammatory bowel disease, malabsorption or chronic diarrhea
  • Stage 3, 4 or 5 Chronic Kidney Disease based on the Modification of Renal Diet (MDRD) formula
  • Use of bone-active medications within the past 6 months including bisphosphonates, estrogen compounds, calcitonin, teriparatide, oral corticosteroids and anticonvulsants
  • Allergy or intolerance to orange juice
  • Allergy or intolerance to sunscreen
  • Prior adult clinical fragility fracture of the hip, spine or wrist or a T-score below -2.5 at the lumbar spine or femur

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53705, United States

Location

Related Publications (5)

  • Hansen KE, Jones AN, Lindstrom MJ, Davis LA, Engelke JA, Shafer MM. Vitamin D insufficiency: disease or no disease? J Bone Miner Res. 2008 Jul;23(7):1052-60. doi: 10.1359/jbmr.080230.

    PMID: 18302509BACKGROUND

  • Ramsubeik K, Keuler NS, Davis LA, Hansen KE. Factors associated with calcium absorption in postmenopausal women: a post hoc analysis of dual-isotope studies. J Acad Nutr Diet. 2014 May;114(5):761-7. doi: 10.1016/j.jand.2013.07.041. Epub 2013 Oct 24.

    PMID: 24209888BACKGROUND

  • Nabak AC, Johnson RE, Keuler NS, Hansen KE. Can a questionnaire predict vitamin D status in postmenopausal women? Public Health Nutr. 2014 Apr;17(4):739-46. doi: 10.1017/S1368980013001973. Epub 2013 Jul 22.

    PMID: 23870503RESULT

  • Hansen KE, Johnson RE, Chambers KR, Johnson MG, Lemon CC, Vo TN, Marvdashti S. Treatment of Vitamin D Insufficiency in Postmenopausal Women: A Randomized Clinical Trial. JAMA Intern Med. 2015 Oct;175(10):1612-21. doi: 10.1001/jamainternmed.2015.3874.

    PMID: 26237520RESULT

  • Vreede AP, Jones AN, Hansen KE. Can serum isotope levels accurately measure intestinal calcium absorption compared to gold-standard methods? Nutr J. 2015 Jul 31;14:73. doi: 10.1186/s12937-015-0065-5.

    PMID: 26227019DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

CholecalciferolVitamin DSugars

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsSecosteroidsMembrane LipidsLipidsCarbohydrates

Results Point of Contact

Title
Dr. Karen E Hansen
Organization
University of Wisconsin - School of Medicine & Public Health
keh@medicine.wisc.edu
608-265-8162

Study Officials

  • Karen E Hansen, MD, MS

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2009

First Posted

July 7, 2009

Study Start

April 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

November 10, 2015

Results First Posted

November 10, 2015

Record last verified: 2015-10

Locations

US(1)