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CompletedNCT01868945D-DOSEUpdated Mar 27, 2015

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

A Phase 1 interventional study of 5 µg/day Hy.D Calcifediol and 10 µg/day Hy.D Calcifediol in Pre-frail Elderly and Frail Elderly, sponsored by DSM Nutritional Products, Inc.. Completed at 1 site in Netherlands. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-27.

Sponsored by DSM Nutritional Products, Inc. · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

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.

02

Conditions studied

  • Pre-frail Elderly
  • Frail Elderly

Keywords

  • Vitamin D3
  • Calcifediol 25
  • Frail
  • Dose-response
03

In context

Lead sponsor

DSM Nutritional Products, Inc. is the lead sponsor of 37 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    5 µg/day Hy.D Calcifediol

    Dietary Supplement: 5 µg/day Hy.D Calcifediol

  • Experimental
    10 µg/day Hy.D Calcifediol

    Dietary Supplement: 10 µg/day Hy.D Calcifediol

  • Experimental
    15 µg/day Hy.D Calcifediol

    Dietary Supplement: 15 µg/day Hy.D Calcifediol

  • Active comparator
    20 µg/day vitamin D3

    Dietary Supplement: 20 µg/day vitamin D3

Interventions

  • Dietary supplement5 µg/day Hy.D Calcifediol

    5 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks

  • Dietary supplement10 µg/day Hy.D Calcifediol

    10 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks

  • Dietary supplement15 µg/day Hy.D Calcifediol

    15 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks

  • Dietary supplement20 µg/day vitamin D3

    20 µg/day vitamin D3 taken together with breakfast for a total period of 24 weeks

06

What researchers measure

Primary outcomes

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

    Outcome measurement: Mean serum 25(OH)D levels at baseline before supplementation of three doses of Hy.D and 1 dose of vitamin D3.

    Time frame: Baseline (day 0)

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

    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.

    Time frame: 4 weeks after initial compound intake

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

    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.

    Time frame: 8 weeks after initial compound intake

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

    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.

    Time frame: 12 weeks after initial compound intake

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

    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.

    Time frame: 16 weeks after initial compound intake

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

    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.

    Time frame: 20 weeks after initial compound intake

  7. Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 24 weeks

    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.

    Time frame: 24 weeks after initial compound intake

Secondary outcomes

  1. Descriptive: 25(OH)D3 serum steady state reached?

    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

    Time frame: 0, 4, 8, 12, 16, 20, 24 weeks after study start

07

Study locations

1 site
  • Wageningen University
    Wageningen, 6700, Netherlands
08

References and documents

Publications

  • Vaes AMM, Tieland M, de Regt MF, Wittwer J, van Loon LJC, de Groot LCPGM. Dose-response effects of supplementation with calcifediol on serum 25-hydroxyvitamin D status and its metabolites: A randomized controlled trial in older adults. Clin Nutr. 2018 Jun;37(3):808-814. doi: 10.1016/j.clnu.2017.03.029. Epub 2017 Mar 31. PubMed 28433267 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 27, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01868945
Lead sponsor
DSM Nutritional Products, Inc.
Responsible party
Sponsor
First posted
Jun 5, 2013
Start date
Apr 2013
Primary completion
Jun 2014
Completion
Jun 2014
Last update
Mar 27, 2015

Study contacts

Lisette De Groot, Prof
principal investigator · Wageningen University
Michael Tieland, PhD
principal investigator · Wageningen University
Luc van Loon, Prof
principal investigator · Maastricht University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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