|- candidate number||5655|
|- NTR Number||NTR1777|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||25-apr-2009|
|- Secondary IDs||NL26675.098.09 / 2009-009600-39 / 09-037 ABR / EudraCT / MEC|
|- Public Title||Effect of vitamin D on the systolic blood pressure in hypertensive
patients with low vitamine D levels.|
|- Scientific Title||Effect of cholecalciferol on the systolic blood pressure in hypertensive, vitamine D insufficient patients.|
|- hypothesis||Does suppletion of vitamine D3 (cholecalciferol) have an effect on the systolic blood pressure in hypertensive, vitamin D insufficient patients?|
1. H0 hypothesis: there is no effect on the systolic blood pressure;
2. H1 hypothesis: the systolic blood pressure decreases with at least 5 mm Hg.
|- Healt Condition(s) or Problem(s) studied||Vitamin D deficiency, Systolic hypertension|
|- Inclusion criteria||1. The patient has signed an informed consent;|
2. The patient is an adult male or female (age 18 yr or above);
3. The patient is diagnosed with a systolic hypertension (> 140 mmHg);
4. The patient is vitamin D insufficient, defined as having a 25-hydroxycholecalciferol concentration between 20-50 nmol/l.
|- Exclusion criteria||1. Using prescribed cholecalciferol supplement (equal to or more than 400 IE = 10 microg/day) after t = -2 months;|
2. MDRD below normal for age/gender;
3. for albumin corrected serum calcium equal to or above 2,60 mmol/L;
4. Existing malignancy which is being treated;
5. Disease of Besnier-Boeck (sarcoidosis);
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2009|
|- planned closingdate||18-dec-2014|
|- Target number of participants||100|
|- Interventions||1. Group 1: 2 oral tablets of cholecalciferol 1000 IE (= 50 microg) each day for 12 months;|
2. Group 2: 2 placebo oral tablets each day for 12 months.
Placebo tablets are manufactured by the Central Hospital Pharmacy, The Hague.
|- Primary outcome||Systolic blood pressure.|
|- Secondary outcome||1. Plasma renin concentration;|
4. Alkaline phosphatase;
5. Parathyroid hormone;
6. The need of adjusting the antihypertensive therapy.
|- Timepoints||1. T = 0, 6, 12 months:|
A. Blood pressure;
C. For albumin corrected serum calcium;
E. Plasma renin activity (PRC);
G. 25-OH-Vitamin D;
H. 1,25-(OH)2-Vitamin D;
I. Parathyroid hormone (PTH);
J. Uric acid;
K. Alkaline phosphatase;
L. Fasting insulin;
M. Fasting glucose;
Q. Creatinine/eGFR (MDRD);
X. Calcium creatinine ratio in urine;
Y. Sodium creatinine ratio in urine;
Z. Abumin creatinine ratio in urine;
AA. Urine phosphate.
2. T = 0, 12 months:
A. 24-hr blood pressure (optional at T = 6 months).
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Drs. W.J. Liefers|
|- CONTACT for SCIENTIFIC QUERIES||Drs. W.J. Liefers|
|- Sponsor/Initiator ||Bronovo Hospital, Dr. Y.W.J. Sijpkens|
(Source(s) of Monetary or Material Support)
|The Bronovo Research Fund|
|- Brief summary||Vitamin D insufficiency is common because of lack of sunshine exposure and too little availability of vitamin-D-rich foodsources. Low vitamin D concentrations are associated with an increased risk of
hypertension, diabetes and cardiovascular diseases, such as myocardial infarction. Suppletion of vitamin D
reduces the all-cause mortality in especially the elderly. Research in relation to low vitamin D concentrations and hypertension shows that:|
1. The prevalence of hypertension increases when distance to the equator increases;
2. In winter measured blood pressures are higher;
3. Relative risk to hypertension increases strongly with 25-hydroxycholecalciferol concentrations below 37,5
4. In the vitamin D insufficient, hypertensive elderly suppletion of the combination of calcium and vitamine
D shows larger decreases in systolic blood pressure and PTH than suppletion of calcium alone;
5. The plasma renin activity (PRA) increases with decreasing vitamin D concentrations.
In this double blind, randomised, placebo-controlled intervention study we want to evaluate the effect of cholecalciferol supplection on the systolic blood pressure in hypertensive patients
with a 25-hydroxycholecalciferol insufficiency. Secondly, the effects on PRC, aldosteron, 25-
hydroxycholecalciferol, alkaline phosphatase, PTH and the effect on the need of adjusting the
antihypertensive therapy are evaluated.
Only policlinical patients from Hospital Bronovo in The Hague, the Netherlands, can be included.
|- Main changes (audit trail)||Deleted Exclusion: 1. Existing cardiovascular disease (i.e. previous myocardial infarction or a vascular disease needing radiologal or surgical intervention);|
D. Plasma renin activity (PRA);
changed to: Plasma renin concentration;
V. Calcium creatinine ratio in urine;
changed to: V. FGF23 Calcium creatinine ratio in urine;
30-sep-2009 - Jurre
Status aangepast naar Open: Actieve patienteninclusie - 20-okt-2009-JUrre
05-Apr-2010: Enkele wijzigingen
Einddatum: 01-Oct-2010 changed to: 01-Jul-2012;
Secondary outcome: plasma renin activity changed to: plasma renin concentration;
Timepoints: C. For albumin corrected serum calciumphosphate changed to: C. For albumin corrected serum calcium; D. Phosphate;
Added: AA. Urine phosphate, and: A. (optional at T = 6 months);
Main changes: Verum tablets (2000 IE) not produced by the Central Hospital Pharmacy, The Hague. Currently available 1000 IE tablets are used in stead.
PRA is replaced with PRC; Urine phosphate added.
|- RECORD||25-apr-2009 - 16-jan-2015|