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Deficiency, Vitamin DD-FitNCT02349282

The Effect of Calcifediol (Hy.D 25 SD/S) and Vitamin D3 on Muscle Strength in a Frail Elderly Population

A study testing Calcifediol 10ug/day and Vitamin D3 20ug/day in people with Deficiency, Vitamin D and Elderly, Frail, run by Wageningen University 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

In an ageing population, the need for interventions to help older people remain healthy, active and independent for as long as possible, increases. Although several studies suggest a beneficial effect of vitamin D3 on maintaining or improving muscle strength and physical functioning, particularly in vulnerable… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Deficiency, Vitamin D, Elderly, Frail
What is being tested?
Calcifediol 10ug/day and Vitamin D3 20ug/day
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
78 participants
Where
1 siteNetherlands
Study dates
Dec 2014to Dec 2015
Phase
Interventional
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 20-50 nmol/L.
  • age 65 or older.
  • physically frail (pre-frail or frail, based on the criteria designed by Fried et al.) (30). 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), self-reported exhaustion (CES-D questionnaire), weakness (grip strength), slow walking speed and low physical activity (Minnesota questionnaire). More details on these criteria are described in chapter 6.3.2.
  • body mass index between 18.5 and 35 kg/m2.
  • willingness and ability to comply with the protocol, including performance of the knee extension strength test.

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; currently diagnosed or undergoing treatment.
Show all 13Show fewer
  • Hypercalcemia: serum calcium adjusted for albumin of > 2.6 nmol/L.
  • Medication: interfering with vitamin D metabolism and vitamin D supplementation (bisphosphonate, PTH treatment, tuberculostatica, anti-epileptica).
  • Subject not able (when medically necessary/ advised) or not willing to stop the use of vitamin D containing supplements during the study.
  • (Expected) increase in exposure to sunlight (e.g. travelling to a sunny resort) during intervention period.
  • Patient heavily consumes alcohol containing products defined as greater than > 21 drinks of alcoholic beverages per week.
  • Planned surgery which can affect study measures (taking into account duration of hospitalisation and recovery).
  • Participation in another clinical trial.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Wageningen University

    Wageningen, Gelderland, 6703HD

Other trials in Netherlands

About this study

Official title: The Effect of Calcifediol (Hy.D 25 SD/S) and Vitamin D3 on Muscle Strength in a Frail Elderly Population: a Randomized, Double-blind, Placebo-controlled Trial.

In an ageing population, the need for interventions to help older people remain healthy, active and independent for as long as possible, increases. Although several studies suggest a beneficial effect of vitamin D3 on maintaining or improving muscle strength and physical functioning, particularly in vulnerable populations, results are contradicting. Randomized, placebo-controlled trials are needed to further establish the effect of vitamin D on muscle strength in the frail elderly population.The primary aim of this study is to determine the effect of daily supplementation with two different forms of vitamin D on muscle strength in frail elderly people over a period of 24 weeks.

Being tested
Calcifediol 10ug/day, Vitamin D3 20ug/day, Placebo
Keywords
muscle strength, physical performance, vitamin D3, Cholecalciferol, Calcifediol
Medical subject headings
Vitamin D Deficiency

What participants receive

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

  • Calcifediol 10ug/dayDietary supplement

    Also called Hy.D

  • Vitamin D3 20ug/dayDietary supplement

    Also called Cholecalciferol

  • PlaceboDietary supplement

Study groups in NCT02349282
Study groupRoleWhat they receive
Calcifediol 10 ug/dayExperimentalCapsule with 10 ug/day Calcifediol taken together with breakfast for a total period of 24 weeks.
Receives: Dietary Supplement: Calcifediol 10ug/day
Vitamin D3 20 ug/dayExperimentalCapsule with 20 ug/day Vitamin D3 taken together with breakfast for a total period of 24 weeks.
Receives: Dietary Supplement: Vitamin D3 20ug/day
PlaceboPlacebo comparatorCapsule without active ingredients, taken together with breakfast for a total period of 24 weeks.
Receives: Dietary Supplement: Placebo

What is being measured

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

  1. Change in muscle strength, knee extension strength (measured by Biodex System)

    measured by Biodex System

    Measured: baseline, week 12, end of study (after 24 weeks supplementation)

Secondary outcomes (15)

  1. Change in knee flexion strength (measured by Biodex System)

    measured by Biodex System

    Measured: baseline, week 12, end of study (after 24 weeks supplementation)

  2. Change in handgrip strength

    Measured: baseline, week 12, end of study (after 24 weeks supplementation)

  3. Change in SPPB

    Measured: baseline, week 12, end of study (after 24 weeks supplementation)

  4. Change in Timed Up and Go test

    Measured: baseline, week 12, end of study (after 24 weeks supplementation)

  5. Change in Postural Body Sway

    Measured: baseline, week 12, end of study (after 24 weeks supplementation)

  6. Change in serum Vitamin D3

    Measured: baseline, week 12, end of study (after 24 weeks supplementation)

  7. Change in serum 25(OH)D

    Measured: baseline, week 12, end of study (after 24 weeks supplementation)

  8. Change in serum 1,25(OH)2D3

    Measured: baseline, week 12, end of study (after 24 weeks supplementation)

  9. Change in serum 24,25(OH)2D

    Measured: baseline, week 12, end of study (after 24 weeks supplementation)

  10. Frequency of falling

    Measured: baseline, week 12, end of study (after 24 weeks supplementation)

  11. Change in muscle fibre type and size (Biopsy)

    Biopsy

    Measured: baseline, end of study (after 24 weeks supplementation)

  12. Change in body composition (DEXA-scan)

    DEXA-scan

    Measured: baseline, end of study (after 24 weeks supplementation)

  13. Change in cognitive functioning (Trail making, Stroop-test, Letter fluency)

    Trail making, Stroop-test, Letter fluency

    Measured: baseline, end of study (after 24 weeks supplementation)

  14. Change in vital Signs (blood pressure and heart rate)

    blood pressure and heart rate

    Measured: baseline, week 12, end of study (after 24 weeks supplementation)

  15. Change in neuromuscular measurements (MUNIX, MUSIX by EMG)

    MUNIX, MUSIX by EMG

    Measured: baseline, end of study (after 24 weeks supplementation)

Timeline

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

  1. First posted28 Jan 2015 (estimated)
  2. Study startDec 2014
  3. Primary completionDec 2015
  4. Study completionDec 2015

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02349282
Sponsor's protocol ID
NL48127.081.148
Acronym
D-Fit
Status last verified
Jan 2016
First submitted
22 Dec 2014
Last updated
11 Jan 2016
Results posted
No
Data monitoring committee
No

Publications

  • Hangelbroek RWJ, Vaes AMM, Boekschoten MV, Verdijk LB, Hooiveld GJEJ, van Loon LJC, de Groot LCPGM, Kersten S. No effect of 25-hydroxyvitamin D supplementation on the skeletal muscle transcriptome in vitamin D deficient frail older adults. BMC Geriatr. 2019 May 28;19(1):151. doi: 10.1186/s12877-019-1156-5.

    PubMed 31138136

  • Vaes AMM, Tieland M, Toussaint N, Nilwik R, Verdijk LB, van Loon LJC, de Groot LCPGM. Cholecalciferol or 25-Hydroxycholecalciferol Supplementation Does Not Affect Muscle Strength and Physical Performance in Prefrail and Frail Older Adults. J Nutr. 2018 May 1;148(5):712-720. doi: 10.1093/jn/nxy024.

    PubMed 30053278

Questions about this trial

What is this clinical trial studying?

A study testing Calcifediol 10ug/day and Vitamin D3 20ug/day in people with Deficiency, Vitamin D and Elderly, Frail, run by Wageningen University 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 5 inclusion and 13 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 11 Jan 2016. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

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?

Change in muscle strength, knee extension strength (measured by Biodex System) (time frame: baseline, week 12, end of study (after 24 weeks supplementation)). 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 NCT02349282, which also lists 2 linked publications.

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 11 Jan 2016.

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