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

This study has been completed.
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology Identifier:
First received: January 20, 2010
Last updated: November 21, 2013
Last verified: November 2013

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.

Condition Intervention Phase
Dietary Supplement: vitamin D
Behavioral: exercise program (rebounding on a trampoline)
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Using Ca-41 Methodology to Assess the Impact of Different Vitamin D Supplementation Levels on Postmenopausal Bone Health

Resource links provided by NLM:

Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • urinary Ca-41/Ca-40 ratio [ Time Frame: March 2010 to January 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • biomarkers of bone metabolism [ Time Frame: March 2010 to January 2011 ] [ Designated as safety issue: No ]
  • urinary iodine [ Time Frame: August 2009 to December 2010 ] [ Designated as safety issue: No ]
    Comparison of spot and 24 h urine samples for the assessment of iodine status (substudy, not related to vitamin D intervention)

Enrollment: 25
Study Start Date: March 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01053481

Human Nutrition Laboratory, Institute of Food, Nutrition and Health, ETH Zurich
Zurich, Switzerland, 8092
Sponsors and Collaborators
Swiss Federal Institute of Technology
DSM Nutritional Products, Inc.
Principal Investigator: Michael B Zimmermann, Prof. Dr. med. ETH Zurich
  More Information

Responsible Party: Prof. Michael B. Zimmermann, Prof. Dr. med, Swiss Federal Institute of Technology Identifier: NCT01053481     History of Changes
Other Study ID Numbers: 2009-04-07-Ca41
Study First Received: January 20, 2010
Last Updated: November 21, 2013
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Vitamin D
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Growth Substances processed this record on April 16, 2014