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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 (D-DOSE)

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ClinicalTrials.gov Identifier: NCT01868945
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : March 27, 2015
Sponsor:
Information provided by (Responsible Party):
DSM Nutritional Products, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Pre-frail Elderly Frail Elderly Dietary Supplement: 5 µg/day Hy.D Calcifediol Dietary Supplement: 10 µg/day Hy.D Calcifediol Dietary Supplement: 15 µg/day Hy.D Calcifediol Dietary Supplement: 20 µg/day vitamin D3 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: 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
Study Start Date : April 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868945


Locations
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Netherlands
Wageningen University
Wageningen, Netherlands, 6700
Sponsors and Collaborators
DSM Nutritional Products, Inc.
Investigators
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Principal Investigator: Lisette De Groot, Prof Wageningen University
Principal Investigator: Michael Tieland, PhD Wageningen University
Principal Investigator: Luc van Loon, Prof Maastricht University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: DSM Nutritional Products, Inc.
ClinicalTrials.gov Identifier: NCT01868945    
Other Study ID Numbers: 2012-10-24-HyD
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: March 27, 2015
Last Verified: March 2015
Keywords provided by DSM Nutritional Products, Inc.:
Vitamin D3
Calcifediol 25
Frail
Dose-response
Additional relevant MeSH terms:
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Vitamin D
Cholecalciferol
Calcifediol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents