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Efficacy of a vitamin D dosing regimen

Efficacy of a vitamin D dosing regimen consisting of a single oral loading dose of 200,000 IU cholecalciferol followed by 100,000 IU orally every 13 weeks in obtaining and maintaining a serum 25-hydroxyvitamin D level between 75 and 220 nmol/L in somatic and psycho-geriatric nursing home residents

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21710
Enrollment
150
Registered
2016-08-05
Start date
2015-10-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D deficiency, Vitamine D deficiëntie

Interventions

The drawing of a single venous blood sample, which is standard care as part of the Vitamin D protocol.

Sponsors

Medisch Centrum Leeuwarden
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The study population comprises residents of 13 somatic and psycho-geriatric nursing homes. Nursing home residents will be screened for eligibility based on the inclusion criteria. In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Subjects must be over 18 years of age. - Subjects must have received vitamin D supplementation according to protocol for at least 4 months (a single oral loading dose of 200,000 IU cholecalciferol followed by at least one maintenance dose of 100,000 IU after 13 weeks).

Exclusion criteria

Exclusion criteria: Not applicable.

Design outcomes

Primary

MeasureTime frame
The primary aim of this study is to determine the efficacy of the established cholecalciferol dosing regimen (a single oral loading dose of 200,000 IU cholecalciferol followed by 100,000 IU orally every 13 weeks) in obtaining and maintaining an adequate serum 25-hydroxyvitamin D level between 75 and 220 nmol/L in somatic and psycho-geriatric nursing home residents.

Secondary

MeasureTime frame
A second aim of this study is to assess the additional effect of the vitamin D dosing regimen on serum PTH and calcium levels, and to determine the influence of (known) variables as possible effect modifiers on the serum 25-hydroxyvitamin D level outcome.

Contacts

Public ContactM.L. Toren

Medisch Centrum Leeuwarden

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)