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van CCT (UK)

Effect of vitamin D on the systolic blood pressure in hypertensive patients with low vitamine D levels.

- candidate number5655
- NTR NumberNTR1777
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-apr-2009
- Secondary IDsNL26675.098.09 / 2009-009600-39 / 09-037 ABR / EudraCT / MEC
- Public TitleEffect of vitamin D on the systolic blood pressure in hypertensive patients with low vitamine D levels.
- Scientific TitleEffect of cholecalciferol on the systolic blood pressure in hypertensive, vitamine D insufficient patients.
- hypothesisDoes 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) studiedVitamin D deficiency, Systolic hypertension
- Inclusion criteria1. 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 criteria1. 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);
6. Pregnancy.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2009
- planned closingdate18-dec-2014
- Target number of participants100
- Interventions1. 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 outcomeSystolic blood pressure.
- Secondary outcome1. Plasma renin concentration;
2. Aldosteron;
3. 25-hydroxycholecalciferol;
4. Alkaline phosphatase;
5. Parathyroid hormone;
6. The need of adjusting the antihypertensive therapy.
- Timepoints1. T = 0, 6, 12 months:
A. Blood pressure;
B. Albumin;
C. For albumin corrected serum calcium;
D. Phosphate;
E. Plasma renin activity (PRC);
F. Aldosteron;
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;
N. HbA1c;
Q. Creatinine/eGFR (MDRD);
R. Hemocytometry;
S. Triglycerides;
T. Cholesterol;
U. LDL-cholesterol;
V. HDL-cholesterol;
W. FGF23;
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 siteN/A
- statusstopped: trial finished
- Sponsor/Initiator Bronovo Hospital, Dr. Y.W.J. Sijpkens
- Funding
(Source(s) of Monetary or Material Support)
The Bronovo Research Fund
- PublicationsN/A
- Brief summaryVitamin 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 nmol/l;
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);
TIMEPOINTS: 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.
- RECORD25-apr-2009 - 16-jan-2015

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