Feasibility study for a larger randomised trial of the effect of taking vitamin D supplements on health and lifespan in men and women aged 65 to 84.

Phase 1

• Conditions: The aim of vitamin D supplementation is to increase circulating 25(OH) vitamin D level in the general population. The aim of the main trial for which this is a feasibility study is to determine whether this will improve general health, which is uncertain.

• Registration Number: EUCTR2011-003699-34-GB
• Lead Sponsor: ondon School of Hygiene & Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-14
• Study Completion: 2017-03-22
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 11376

Inclusion Criteria

• Age = 65 years and = 84 years at enrolment • Contactable by telephone, able to receive postal recorded deliveries, and able to attend enrolment at the GP surgery • GP notes for the previous year are available
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 1600

Exclusion Criteria

• Known active tuberculosis, sarcoidosis, hyperparathyroidism, past or present nephrolithiasis, vitamin D intolerance, referral for suspected hepatic or renal dysfunction, terminal illness, any malignancy other than non-melanoma skin cancer not in remission for = 3 years • Planning to move from the GP practice or to emigrate within 5 years • Any other condition that in the PI’s or CI’s judgement might compromise participant safety or compliance, interfere with evaluation or preclude completion of the study. • Baseline corrected serum calcium > 2.65 mmol/L • Taking dietary supplement or other medication containing >400 IU (10 micrograms) per day vitamin D • Treatment with any other investigational medical product or device up to 4 months before first dose of IMP • Concomitant therapy with any of the following: carbamazepine, phenobarbital, phenytoin, primidone, digoxin, oral 1-alpha-hydroxylated vitamin D preparations (e.g. alfalcalcidol, calcitriol) or the combination of a thiazide diuretic (e.g. bendrofluazide, metolazone) with a calcium supplement

Study & Design

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