Osteopenia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTvitamin D
Vitamin D supplement
BEHAVIORALexercise program (rebounding on a trampoline)
40 days at 30 min/d
Sponsors
DSM Nutritional Products, Inc.
Swiss Federal Institute of Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
55 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| urinary Ca-41/Ca-40 ratio | March 2010 to January 2011 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Switzerland
Outcome results
None listed