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 (D-DOSE)

March 26, 2015 updated by: DSM Nutritional Products, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Wageningen, Netherlands, 6700
        • Wageningen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 25(OH)D levels between 25 - 50 nmol/L;
  • Age 65 and older;
  • Physically frail, based on the criteria designed by Fried et al. [1]. Frailty will be defined as a clinical syndrome in which one or more of the following criteria are present: unintentional weight loss (4.5 kg in past year), selfreported exhaustion (CES-D questionnaire), weakness (grip strength), slow walking speed and low physical activity (Minnesota questionnaire). These criteria are easily assessable and have been commonly used to determine frailty;
  • Men and women;
  • Body mass index between 20 and 35 kg/m2 (used for stratification);
  • Willingness and ability to comply with the protocol.

Exclusion Criteria:

  • Medical Illness: malabsorption syndrome: known intestinal malabsorption, celiac diseases, inflammatory bowel disease; diseases that may enhance serum calcium concentration: sarcoidosis, lymphoma, kidney stone in the last 10 years, primary hyperparathyroidism; abnormal indices of calcium metabolism, uncontrolled hypocalcaemia; diagnosed renal insufficiency, diagnosed cancer, diagnosed liver failure.
  • Hypercalcemia : serum calcium adjusted for albumin of > 2.6 nmol/L.
  • Medication: bisphosphonate or Parathyroid hormone (PTH) treatment, tuberculostatics, epilepsy medication, interfering with vitamin D metabolism and vitamin D supplementation.
  • Use of vitamin D supplementation in the last three months (excluding multivitamin supplementation).
  • Not willing to stop the use of multivitamin supplementation during the study.
  • (Expected) increase in exposure to sunlight (e.g. travelling to a sunny resort).
  • Patient heavily consumes alcohol containing products defined as greater than (>) 3 drinks (beer, wine, or distilled spirits) of alcoholic beverages per day.
  • Donating blood in the period of 2 months before, until 1 month after the end of the study.
  • Planned surgery.
  • Participation in another clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 5 µg/day Hy.D Calcifediol
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
Experimental: 10 µg/day Hy.D Calcifediol
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
Experimental: 15 µg/day Hy.D Calcifediol
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
Active Comparator: 20 µg/day vitamin D3
Dietary supplement: 20 µg/day vitamin D3
20 µg/day vitamin D3 taken together with breakfast for a total period of 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups at baseline
Time Frame: Baseline (day 0)
Outcome measurement: Mean serum 25(OH)D levels at baseline before supplementation of three doses of Hy.D and 1 dose of vitamin D3.
Baseline (day 0)
Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 4 weeks
Time Frame: 4 weeks after initial compound intake
Outcome measurement: Mean serum 25(OH)D levels after 4 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3.
4 weeks after initial compound intake
Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 8 weeks
Time Frame: 8 weeks after initial compound intake
Outcome measurement: Mean serum 25(OH)D levels after 8 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3.
8 weeks after initial compound intake
Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 12 weeks
Time Frame: 12 weeks after initial compound intake
Outcome measurement: Mean serum 25(OH)D levels after 12 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3.
12 weeks after initial compound intake
Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 16 weeks
Time Frame: 16 weeks after initial compound intake
Outcome measurement: Mean serum 25(OH)D levels after 16 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3.
16 weeks after initial compound intake
Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 20 weeks
Time Frame: 20 weeks after initial compound intake
Outcome measurement: Mean serum 25(OH)D levels after 20 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3.
20 weeks after initial compound intake
Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 24 weeks
Time Frame: 24 weeks after initial compound intake
Outcome measurement: Mean serum 25(OH)D levels after 24 weeks of supplementation of three doses of Hy.D and 1 dose of vitamin D3.
24 weeks after initial compound intake

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Descriptive: 25(OH)D3 serum steady state reached?
Time Frame: 0, 4, 8, 12, 16, 20, 24 weeks after study start
Assessment if 25(OH)D3 serum levels will reach a steady state after 24 weeks supplementation of 3 doses of Hy.D and 1 dose of vitamin D3
0, 4, 8, 12, 16, 20, 24 weeks after study start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DSM Nutritional Products, Inc.

Investigators

  • Principal Investigator: Lisette De Groot, Prof, Wageningen University
  • Principal Investigator: Michael Tieland, PhD, Wageningen University
  • Principal Investigator: Luc van Loon, Prof, Maastricht University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

May 24, 2013

First Submitted That Met QC Criteria

May 31, 2013

First Posted (Estimate)

June 5, 2013

Study Record Updates

Last Update Posted (Estimate)

March 27, 2015

Last Update Submitted That Met QC Criteria

March 26, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-10-24-HyD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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