Using Ca-41 Methodology to Assess the Impact of Different... | NCT01053481

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Jan 20, 2010

First Submission Date that Met QC Criteria

Jan 20, 2010

First Posted Date

Jan 21, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2013

Last Update Posted Date

Nov 25, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Michael B. Zimmermann, Prof. Dr. med, Swiss Federal Institute of TechnologyPrincipal Investigator

Lead Sponsor

Swiss Federal Institute of TechnologyOTHER

Collaborators

Name	Class
dsm-firmenich Switzerland AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

In a substudy - not related to the vitamin D intervention - spot and 24 h urine samples are compared with regard to the assessment of iodine status in Swiss post-menopausal women.

In an short subsequent study using five of the subjects who participated in the original trial, the effect of a 40 d-exercise program (rebounding on a trampoline) on Ca-41 excretion will be observed.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Vitamin D	Experimental	Vitamin D supplement	Dietary Supplement: vitamin D Behavioral: exercise program (rebounding on a trampoline)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vitamin D	Dietary Supplement	Vitamin D supplement	Vitamin D
exercise program (rebounding on a trampoline)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
urinary Ca-41/Ca-40 ratio		March 2010 to January 2011

Secondary Outcomes

Measure	Description	Time Frame
biomarkers of bone metabolism		March 2010 to January 2011
urinary iodine	Comparison of spot and 24 h urine samples for the assessment of iodine status (substudy, not related to vitamin D intervention)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michael B Zimmermann, Prof. Dr. med.	ETH Zurich	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Human Nutrition Laboratory, Institute of Food, Nutrition and Health, ETH Zurich		Zurich		8092	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17576167	Background	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.
17033771

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D012632	Secosteroids
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds