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Using Ca-41 Methodology to Assess the Impact of Different Vitamin D Supplementation Levels on Postmenopausal Bone Health

NCT ID: NCT01053481

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Osteopenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Vitamin D

Vitamin D supplement

Group Type EXPERIMENTAL

vitamin D

Intervention Type DIETARY_SUPPLEMENT

Vitamin D supplement

exercise program (rebounding on a trampoline)

Intervention Type BEHAVIORAL

40 days at 30 min/d

Interventions

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vitamin D

Vitamin D supplement

Intervention Type DIETARY_SUPPLEMENT

exercise program (rebounding on a trampoline)

40 days at 30 min/d

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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DSM Nutritional Products, Inc.

INDUSTRY

Sponsor Role collaborator

Swiss Federal Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Prof. Michael B. Zimmermann

Prof. Dr. med

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael B Zimmermann, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

ETH Zurich

Locations

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

Zurich, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 17576167 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17033771 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26338885 (View on PubMed)

Other Identifiers

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2009-04-07-Ca41

Identifier Type: -

Identifier Source: org_study_id