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

Early Phase 1

Completed

• Conditions: Osteopenia
• Interventions: Dietary Supplement: vitamin D; Behavioral: exercise program (rebounding on a trampoline)

• Registration Number: NCT01053481
• Lead Sponsor: Swiss Federal Institute of Technology

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.

Study Timeline

• Study First Submitted: 2010-01-20
• Study First Submitted QC: 2010-01-20
• Study First Posted: 2010-01-21
• Study Start: 2010-03
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-21
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vitamin D	vitamin D	Vitamin D supplement
Vitamin D	exercise program (rebounding on a trampoline)	Vitamin D supplement

Primary Outcome Measures

Name	Time	Method
urinary Ca-41/Ca-40 ratio	March 2010 to January 2011

Secondary Outcome Measures

Name	Time	Method
biomarkers of bone metabolism	March 2010 to January 2011
urinary iodine	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)

Trial Locations

Locations (1)

Human Nutrition Laboratory, Institute of Food, Nutrition and Health, ETH Zurich; 🇨🇭 Zurich, Switzerland