NCT01868945

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 27, 2015

Status Verified

March 1, 2015

Enrollment Period

1.2 years

First QC Date

May 24, 2013

Last Update Submit

March 26, 2015

Conditions

Pre-frail ElderlyFrail Elderly

Keywords

Vitamin D3Calcifediol 25FrailDose-response

Outcome Measures

Primary Outcomes (7)

  • 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.

    Baseline (day 0)

  • 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.

    4 weeks after initial compound intake

  • 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.

    8 weeks after initial compound intake

  • 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.

    12 weeks after initial compound intake

  • 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.

    16 weeks after initial compound intake

  • 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.

    20 weeks after initial compound intake

  • 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.

    24 weeks after initial compound intake

Secondary Outcomes (1)

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

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

Study Arms (4)

5 µg/day Hy.D Calcifediol

EXPERIMENTAL
Dietary Supplement: 5 µg/day Hy.D Calcifediol

10 µg/day Hy.D Calcifediol

EXPERIMENTAL
Dietary Supplement: 10 µg/day Hy.D Calcifediol

15 µg/day Hy.D Calcifediol

EXPERIMENTAL
Dietary Supplement: 15 µg/day Hy.D Calcifediol

20 µg/day vitamin D3

ACTIVE COMPARATOR
Dietary Supplement: 20 µg/day vitamin D3

Interventions

5 µg/day Hy.D CalcifediolDIETARY_SUPPLEMENT

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

5 µg/day Hy.D Calcifediol
10 µg/day Hy.D CalcifediolDIETARY_SUPPLEMENT

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

10 µg/day Hy.D Calcifediol
15 µg/day Hy.D CalcifediolDIETARY_SUPPLEMENT

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

15 µg/day Hy.D Calcifediol
20 µg/day vitamin D3DIETARY_SUPPLEMENT

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

20 µg/day vitamin D3

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University

Wageningen, Wageningen, 6700, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 28433267DERIVED

MeSH Terms

Interventions

Cholecalciferol

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Lisette De Groot, Prof

    Wageningen University

    PRINCIPAL INVESTIGATOR

  • Michael Tieland, PhD

    Wageningen University

    PRINCIPAL INVESTIGATOR

  • Luc van Loon, Prof

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2013

First Posted

June 5, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

March 27, 2015

Record last verified: 2015-03

Locations

NL(1)