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AzTrials

Pre-frail ElderlyPhase 1D-DOSENCT01868945

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 study testing 5 µg/day Hy.D Calcifediol, 10 µg/day Hy.D Calcifediol and 15 µg/day Hy.D Calcifediol in people with Pre-frail Elderly and Frail Elderly, run by dsm-firmenich Switzerland AG at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Pre-frail Elderly, Frail Elderly
What is being tested?
5 µg/day Hy.D Calcifediol, 10 µg/day Hy.D Calcifediol and 15 µg/day Hy.D Calcifediol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteNetherlands
Study dates
Apr 2013to Jun 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Wageningen University

    Wageningen, Wageningen, 6700

Other trials in Netherlands

About this study

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.

Being tested
5 µg/day Hy.D Calcifediol, 10 µg/day Hy.D Calcifediol, 15 µg/day Hy.D Calcifediol, 20 µg/day vitamin D3
Keywords
Vitamin D3, Calcifediol 25, Frail, Dose-response

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 5 µg/day Hy.D CalcifediolDietary supplement

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

  • 10 µg/day Hy.D CalcifediolDietary supplement

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

  • 15 µg/day Hy.D CalcifediolDietary supplement

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

  • 20 µg/day vitamin D3Dietary supplement

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

Study groups in NCT01868945
Study groupRoleWhat they receive
5 µg/day Hy.D CalcifediolExperimentalNot described
Receives: Dietary Supplement: 5 µg/day Hy.D Calcifediol
10 µg/day Hy.D CalcifediolExperimentalNot described
Receives: Dietary Supplement: 10 µg/day Hy.D Calcifediol
15 µg/day Hy.D CalcifediolExperimentalNot described
Receives: Dietary Supplement: 15 µg/day Hy.D Calcifediol
20 µg/day vitamin D3Active comparatorNot described
Receives: Dietary Supplement: 20 µg/day vitamin D3

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 24 weeks after initial compound intake

Secondary outcomes (1)

  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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01868945
Sponsor's protocol ID
2012-10-24-HyD
Acronym
D-DOSE
Status last verified
Mar 2015
First submitted
24 May 2013
Last updated
27 Mar 2015
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 5 µg/day Hy.D Calcifediol, 10 µg/day Hy.D Calcifediol and 15 µg/day Hy.D Calcifediol in people with Pre-frail Elderly and Frail Elderly, run by dsm-firmenich Switzerland AG at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups at baseline (time frame: Baseline (day 0)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01868945, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2015.

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