Clinical trial NCT01868945: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pre-frail Elderly
Frail Elderly
Keywords: Vitamin D3
Calcifediol 25
Frail
Dose-response
Lead sponsor: DSM Nutritional Products, Inc.
Sponsor class: INDUSTRY
First posted: 2013-06-05
Enrollment: 59
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups at baseline
timeFrame: Baseline (day 0)
measure: Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 4 weeks
timeFrame: 4 weeks after initial compound intake
measure: Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 8 weeks
timeFrame: 8 weeks after initial compound intake
measure: Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 12 weeks
timeFrame: 12 weeks after initial compound intake
measure: Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 16 weeks
timeFrame: 16 weeks after initial compound intake
measure: Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 20 weeks
timeFrame: 20 weeks after initial compound intake
measure: Mean serum 25(OH)D levels in Hy.D and vitamin D3 supplemented groups after 24 weeks
timeFrame: 24 weeks after initial compound intake
Secondary outcomes:
measure: Descriptive: 25(OH)D3 serum steady state reached?
timeFrame: 0, 4, 8, 12, 16, 20, 24 weeks after study start
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University
Study officials:
affiliation: Wageningen University
name: Lisette De Groot, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Wageningen University
name: Michael Tieland, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University
name: Luc van Loon, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.