NCT01868945

Dose Finding Study in Physically Frail Elderly to Measure 25(OH) Vitamin D Levels After Supplementation With Hy.D Calcifediol 25 SD/S and Vitamin D3

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: dsm-firmenich Switzerland AG · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the dose of Hy.D Calcifediol 25 SD/S (a metabolite of vitamin D3) which will achieve the range of mean serum 25(OH)D between 75-100nmol/L in physically frail elderly people after 24 weeks of daily supplementation with different doses of Hy.D Calcifediol 25 SD/S compared to vitamin D3.

Conditions

• Pre-frail Elderly
• Frail Elderly

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	5 µg/day Hy.D Calcifediol	5 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
DIETARY_SUPPLEMENT	10 µg/day Hy.D Calcifediol	10 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
DIETARY_SUPPLEMENT	15 µg/day Hy.D Calcifediol	15 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
DIETARY_SUPPLEMENT	20 µg/day vitamin D3	20 µg/day vitamin D3 taken together with breakfast for a total period of 24 weeks

Timeline

• Start date: 2013-04-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-06-05
• Last updated: 2015-03-27

Locations

1 site across 1 country: Netherlands