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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

NCT01868945 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2015-03-27

No results posted yet for this study

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

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

Sponsors & Collaborators

  • DSM Nutritional Products, Inc.

    lead INDUSTRY

Principal Investigators

  • Lisette De Groot, Prof · Wageningen University

  • Michael Tieland, PhD · Wageningen University

  • Luc van Loon, Prof · Maastricht University

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01868945 on ClinicalTrials.gov