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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

Phase 1
Completed
Conditions
Pre-frail Elderly
Frail Elderly
Registration Number
NCT01868945
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
59
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 24 weeks24 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.

Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups at baselineBaseline (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.

Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 4 weeks4 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.

Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 8 weeks8 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.

Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 12 weeks12 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.

Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 16 weeks16 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.

Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 20 weeks20 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.

Secondary Outcome Measures
NameTimeMethod
Descriptive: 25(OH)D3 serum steady state reached?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

Trial Locations

Locations (1)

Wageningen University

🇳🇱

Wageningen, Netherlands

Wageningen University
🇳🇱Wageningen, Netherlands

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