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

Primary Purpose

Osteopenia

Status
Completed
Phase
Early Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
vitamin D
exercise program (rebounding on a trampoline)
Sponsored by
Swiss Federal Institute of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteopenia

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Vitamin D

Arm Description

Vitamin D supplement

Outcomes

Primary Outcome Measures

urinary Ca-41/Ca-40 ratio

Secondary Outcome Measures

biomarkers of bone metabolism
urinary iodine
Comparison of spot and 24 h urine samples for the assessment of iodine status (substudy, not related to vitamin D intervention)

Full Information

First Posted
January 20, 2010
Last Updated
November 21, 2013
Sponsor
Swiss Federal Institute of Technology
Collaborators
DSM Nutritional Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01053481
Brief Title
Using Ca-41 Methodology to Assess the Impact of Different Vitamin D Supplementation Levels on Postmenopausal Bone Health
Official Title
Using Ca-41 Methodology to Assess the Impact of Different Vitamin D Supplementation Levels on Postmenopausal Bone Health
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Swiss Federal Institute of Technology
Collaborators
DSM Nutritional Products, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vitamin D
Arm Type
Experimental
Arm Description
Vitamin D supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
vitamin D
Intervention Description
Vitamin D supplement
Intervention Type
Behavioral
Intervention Name(s)
exercise program (rebounding on a trampoline)
Intervention Description
40 days at 30 min/d
Primary Outcome Measure Information:
Title
urinary Ca-41/Ca-40 ratio
Time Frame
March 2010 to January 2011
Secondary Outcome Measure Information:
Title
biomarkers of bone metabolism
Time Frame
March 2010 to January 2011
Title
urinary iodine
Description
Comparison of spot and 24 h urine samples for the assessment of iodine status (substudy, not related to vitamin D intervention)
Time Frame
August 2009 to December 2010

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael B Zimmermann, Prof. Dr. med.
Organizational Affiliation
ETH Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Human Nutrition Laboratory, Institute of Food, Nutrition and Health, ETH Zurich
City
Zurich
ZIP/Postal Code
8092
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
17576167
Citation
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.
Results Reference
background
PubMed Identifier
17033771
Citation
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.
Results Reference
background
PubMed Identifier
26338885
Citation
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.
Results Reference
derived

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

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