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

Osteopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01053481
• Other study ID #: 2009-04-07-Ca41
• Status: Completed
• Phase: Phase 0
• First received: January 20, 2010
• Last updated: November 21, 2013
• Start date: March 2010
• Est. completion date: October 2011

Study information

• Verified date: November 2013
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Osteopenia

Intervention

Dietary Supplement:
• vitamin D
Vitamin D supplement

Behavioral:
• exercise program (rebounding on a trampoline)
40 days at 30 min/d

Locations

Country	Name	City	State
Switzerland	Human Nutrition Laboratory, Institute of Food, Nutrition and Health, ETH Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	DSM Nutritional Products, Inc.

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Denk E, Hillegonds D, Hurrell RF, Vogel J, Fattinger K, Häuselmann 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. — View 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. Epub 2006 Oct 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	urinary Ca-41/Ca-40 ratio		March 2010 to January 2011	No
Secondary	biomarkers of bone metabolism		March 2010 to January 2011	No
Secondary	urinary iodine	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	No