NCT01053481

Brief Summary

The purpose of this study is to determine whether increasing levels of serum 25(OH)Vitamin D as achieved by oral supplementation higher than the current recommendations are associated with a less negative bone calcium balance in post-menopausal Swiss women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Mar 2010

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

January 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 21, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

1.6 years

First QC Date

January 20, 2010

Last Update Submit

November 21, 2013

Conditions

Osteopenia

Outcome Measures

Primary Outcomes (1)

  • urinary Ca-41/Ca-40 ratio

    March 2010 to January 2011

Secondary Outcomes (2)

  • biomarkers of bone metabolism

    March 2010 to January 2011

  • urinary iodine

    August 2009 to December 2010

Study Arms (1)

Vitamin D

EXPERIMENTAL

Vitamin D supplement

Dietary Supplement: vitamin DBehavioral: exercise program (rebounding on a trampoline)

Interventions

vitamin DDIETARY_SUPPLEMENT

Vitamin D supplement

Vitamin D
exercise program (rebounding on a trampoline)BEHAVIORAL

40 days at 30 min/d

Vitamin D

Eligibility Criteria

Age55 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • apparently healthy women, at least 5 years post-menopausal
  • BMI 18-30
  • no HRT
  • no regular intake of Ca or vit D supplements
  • wiling and able to give written informed consent and to understand, participate and comply with study requirements
  • non-smokers
  • no long travels (\>3 wk) planned within study period

You may not qualify if:

  • diseases that predispose to osteoporosis
  • history of fragility fractures
  • currently on a weight reduction program
  • excessive physical activity
  • diseases influencing calcium metabolism (thyroid, parathyroid, adrenal disorders etc.)
  • regular intake of medication affecting calcium metabolism
  • osteoporosis (T-score below -2.5)
  • history of psychological illness likely to interfere with the subject's ability to understand the requirements of the study
  • participation in concurrent studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Nutrition Laboratory, Institute of Food, Nutrition and Health, ETH Zurich

Zurich, 8092, Switzerland

Location

Related Publications (3)

  • Denk E, Hillegonds D, Hurrell RF, Vogel J, Fattinger K, Hauselmann HJ, Kraenzlin M, Walczyk T. Evaluation of 41calcium as a new approach to assess changes in bone metabolism: effect of a bisphosphonate intervention in postmenopausal women with low bone mass. J Bone Miner Res. 2007 Oct;22(10):1518-25. doi: 10.1359/jbmr.070617.

    PMID: 17576167BACKGROUND

  • Denk E, Hillegonds D, Vogel J, Synal A, Geppert C, Wendt K, Fattinger K, Hennessy C, Berglund M, Hurrell RF, Walczyk T. Labeling the human skeleton with 41Ca to assess changes in bone calcium metabolism. Anal Bioanal Chem. 2006 Nov;386(6):1587-602. doi: 10.1007/s00216-006-0795-5. Epub 2006 Oct 11.

    PMID: 17033771BACKGROUND

  • Schild A, Herter-Aeberli I, Fattinger K, Anderegg S, Schulze-Konig T, Vockenhuber C, Synal HA, Bischoff-Ferrari H, Weber P, von Eckardstein A, Zimmermann MB. Oral Vitamin D Supplements Increase Serum 25-Hydroxyvitamin D in Postmenopausal Women and Reduce Bone Calcium Flux Measured by 41Ca Skeletal Labeling. J Nutr. 2015 Oct;145(10):2333-40. doi: 10.3945/jn.115.215004. Epub 2015 Sep 2.

    PMID: 26338885DERIVED

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Michael B Zimmermann, Prof. Dr. med.

    ETH Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med

Study Record Dates

First Submitted

January 20, 2010

First Posted

January 21, 2010

Study Start

March 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

November 25, 2013

Record last verified: 2013-11

Locations

CH(1)