BEST-D: A trial to identify the best suitable oral daily dose of vitamin D supplement required to optimise blood levels

Phase 1

• Conditions: BEST-D is a trial assessing the efficacy and safety of vitamin D3 supplements (two doses 50µg and 100µg); hence there are no specific medical conditions under study. Volunteers aged 65 years or older who may or may not have other diseases will be included (except those specifically excluded).; MedDRA version: 18.1 Level: LLT Classification code 10047630 Term: Vitamin depletion System Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-005763-24-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2014-03-10
• Study Start: 2016-02-18
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 305

Inclusion Criteria

Participants are eligible for enrolment in the study if they are:

•Age = 65 years
•Living in the community
•Ambulatory

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 300

Exclusion Criteria

The GP will screen the practice records for all patients aged 65 years or greater who are living in the community to check for the following exclusion criteria using a screening questionnaire. In addition, the study nurse will check the exclusion criteria directly with all potential participants at their initial study visit.

Exclusion criteria
•Nursing home residents
•Regular use of vitamin D supplements with >400 IU (10 mcg) vitamin D daily
•Use of alendronate, risedronate, zoledronic acid, parathyroid hormone, or calcitonin
•Medically diagnosed dementia
•History of hypercalcaemia, hyperparathyroidism, lymphoma, sarcoidosis, active tuberculosis
•History of renal calculus
•Known to be poorly compliant with clinic visits or with taking medication
•Recent history of alcohol or substance misuse or abuse
•Medical history that might limit the ability to take the study
treatment for the duration of the study (e.g. terminal illness)
•Regular prescribed calcium supplements.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified