Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
DSM Nutritional Products, Inc.
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01053481
First received: January 20, 2010
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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
Osteopenia
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.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01053481

Locations
Switzerland
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.
Investigators
Principal Investigator: Michael B Zimmermann, Prof. Dr. med. ETH Zurich
  More Information

Publications:
Responsible Party: Prof. Michael B. Zimmermann, Prof. Dr. med, Swiss Federal Institute of Technology
ClinicalTrials.gov 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:
Ergocalciferols
Vitamin D
Vitamins
Bone Density Conservation Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014