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

November 21, 2013 updated by: Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8092
        • Human Nutrition Laboratory, Institute of Food, Nutrition and Health, ETH Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vitamin D
Vitamin D supplement
Dietary supplement: vitamin D
Vitamin D supplement
Behavioral: exercise program (rebounding on a trampoline)
40 days at 30 min/d

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biomarkers of bone metabolism
Time Frame: March 2010 to January 2011
March 2010 to January 2011
urinary iodine
Time Frame: August 2009 to December 2010
Comparison of spot and 24 h urine samples for the assessment of iodine status (substudy, not related to vitamin D intervention)
August 2009 to December 2010

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Swiss Federal Institute of Technology

Collaborators

DSM Nutritional Products, Inc.

Investigators

  • Principal Investigator: Michael B Zimmermann, Prof. Dr. med., ETH Zurich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

January 20, 2010

First Submitted That Met QC Criteria

January 20, 2010

First Posted (Estimate)

January 21, 2010

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 21, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-04-07-Ca41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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