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Completed

NCT Number: NCT01053481

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

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.

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Key information

Conditions

Osteopenia Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

55 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

Human Nutrition Laboratory, Institute of Food, Nutrition and Health, ETH Zurich

Zurich, 8092, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D

Dietary Supplement

Vitamin D supplement

exercise program (rebounding on a trampoline)

Behavioral

40 days at 30 min/d

Primary outcomes

  1. urinary Ca-41/Ca-40 ratio

    Time frame: March 2010 to January 2011

Secondary outcomes

  1. biomarkers of bone metabolism

    Time frame: March 2010 to January 2011

  2. 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)

Sponsors and collaborators

Lead sponsor

Swiss Federal Institute of Technology

Other

Collaborators

  • dsm-firmenich Switzerland AG

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jan 21, 2010
Registry last updated
Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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