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Daily Vitamin D Supplementation Compared to a Loading Dose and Monthly Supplementation in Elderly Nursing Home Residents (VIDIV)

Primary Purpose

Vitamin D Deficiency in Older Persons

Status

Completed

Phase

Phase 3

Locations

Netherlands

Study Type

Interventional

Intervention

loading dose Vitamin D and 50.000 IU vit D3/month

loading dose and 25.000 IU vit D3/month

Vitamin D 800 IU /day

About this trial

This is an interventional treatment trial for Vitamin D Deficiency in Older Persons focused on measuring Vitamin D, Colecalciferol, Nursing home, Loading dose

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Long term indication for living in a residential home for the elderly
Age > 65 years
Vitamin D deficiency (serum 25- hydroxycholecholecalciferol (25(OH)D3 < 50 nmol/l)
Informed Consent

Exclusion Criteria:

Hypercalcemia (serum CA > 2.60 mmol/l)
Life expectancy < 1/2 year
Multivitamin use including > 400 IE vit D
Non-functional dominant arm

Sites / Locations

Alysis Zorggroep, verpleeghuis zevenaar

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

loading dose and 50.000 IU vit D3/month

Loading dose and 25.000 IU vit D3/month

800 IU vit D3/dag

Arm Description

Loading dose based on body weight and baseline serum 25 (OH)D level + 50.000 IU vit D3/month consolidation

Loading dose based on body weight and baseline serum 25(OH)D level + 25.000 IU vit D3/month consolidation therapy

800 IU vit D3/dag

Outcomes

Primary Outcome Measures

Proportion of patients reaching an adequate serum 25(OH)D level (75-150 nmol/l)

Secondary Outcome Measures

Proportion of patients reaching a serum 25(OH)D level > 220 nmol/l

Handgrip strength

Distance achieved in a 2 minute walk test

Full Information

NCT ID

NCT01168544

First Posted

July 22, 2010

Last Updated

January 3, 2013

Sponsor

Rijnstate Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01168544

Brief Title

Daily Vitamin D Supplementation Compared to a Loading Dose and Monthly Supplementation in Elderly Nursing Home Residents

Acronym

VIDIV

Official Title

Vitamin D Supplementation in Elderly Nursing Home Residents: Daily Supplementation Compared to a Loading Dose an Monthly Supplementation, a Randomised Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

May 2011 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Rijnstate Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Vitamin D deficiency is common in older persons, in particular in residents of nursing homes. This is mainly explained by the fact that older persons do not often go outside in the sunshine. On top of that the capacity of the skin to synthesize provitamin D is decreased and dietary vitamin D intake is low. Vitamin D deficiency leads to osteoporosis, falls and fractures. To prevent morbidity and mortality due to falls and fractures it seems logical to supplement vit D in order to correct the deficiency. The advised daily dose of vit D supplementation is 800 IU. Several studies showed that with this dose the required serum 25(OH)D levels will not be reached. primary objective of this study is: to investigate whether with a loading dose based on body weight and baseline serum 25(OH)D level more patients reach adequate serum 25(OH)D levels compared to 800 IU a day. to determine the best consolidation treatment. Secondary objective is a loading dose based on body weight and baseline serum 25(OH)D level safe to use in residents of nursing homes. is there a relation between the increase in serum 25(OH)D level and muscle strength (handgrip strength). is there a relation between the increase in serum 25(OH)D level and mobility (2 minute walk test). Study design: Randomised trial with 3 study groups: Group 1a. loading dose based on body weight and baseline serum 25(OH)D level + 50.000 IU vit D3/month consolidation therapy. Group 1b. loading dose based on body weight and baseline serum 25(OH)D level + 25.000 IU vit D3/month consolidation therapy. Group 2. 800 IU vit D3/ dag. Study population: Vitamine D deficient residents of nursing homes, 65 years or older.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vitamin D Deficiency in Older Persons

Keywords

Vitamin D, Colecalciferol, Nursing home, Loading dose

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

loading dose and 50.000 IU vit D3/month

Arm Type

Experimental

Arm Description

Loading dose based on body weight and baseline serum 25 (OH)D level + 50.000 IU vit D3/month consolidation

Arm Title

Loading dose and 25.000 IU vit D3/month

Arm Type

Experimental

Arm Description

Loading dose based on body weight and baseline serum 25(OH)D level + 25.000 IU vit D3/month consolidation therapy

Arm Title

800 IU vit D3/dag

Arm Type

Active Comparator

Arm Description

800 IU vit D3/dag

Intervention Type

Dietary Supplement

Intervention Name(s)

loading dose Vitamin D and 50.000 IU vit D3/month

Intervention Description

loading dose based on body weight and baseline serum 25(OH)D level + 50.000 IU vit D3/month consolidation therapy

Intervention Type

Dietary Supplement

Intervention Name(s)

loading dose and 25.000 IU vit D3/month

Intervention Description

loading dose based on body weight and baseline serum 25(OH)D level + 25.000 IU vit D3/month consolidation therapy

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin D 800 IU /day

Intervention Description

800 IU vit D3/day

Primary Outcome Measure Information:

Title

Proportion of patients reaching an adequate serum 25(OH)D level (75-150 nmol/l)

Secondary Outcome Measure Information:

Title

Proportion of patients reaching a serum 25(OH)D level > 220 nmol/l

Title

Handgrip strength

Title

Distance achieved in a 2 minute walk test

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Long term indication for living in a residential home for the elderly Age > 65 years Vitamin D deficiency (serum 25- hydroxycholecholecalciferol (25(OH)D3 < 50 nmol/l) Informed Consent Exclusion Criteria: Hypercalcemia (serum CA > 2.60 mmol/l) Life expectancy < 1/2 year Multivitamin use including > 400 IE vit D Non-functional dominant arm

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

D.T.W. Salemink, Drs.

Organizational Affiliation

Alysis Zorggroep

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alysis Zorggroep, verpleeghuis zevenaar

City

Zevenaar

State/Province

Gelderland

ZIP/Postal Code

6900 GA

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

Daily Vitamin D Supplementation Compared to a Loading Dose and Monthly Supplementation in Elderly Nursing Home Residents

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