PRIMARY• To investigate whether calcium supplementation, in addition to standard induction therapy, decreases intestinal permeability (Chroom EDTA) in patients with active ulcerative colitis.• To observe whether calcium supplementation, in addition…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-intestinal permeability
-diarrhea
Secondary outcome
-percentage patients with a clinical response and clinical remission at 2-4-6-9
and 12 weeks
-percentage patients needing oral steroids
-inflammatory activity as measured by inflammation markers in blood and feces
(fecal blood, calprotectin, mucins, and pancreatitis associated protein (PAP))
Background summary
We have shown in several controlled studies that dietary calcium improves gut
health. This is based on several mechanisms. Besides preventing intestinal
bacterial translocation, calcium has cytoprotective effects as shown in several
studies in the field of colon carcinogenesis. By precipitating irritating bile
acids and fatty acids, supplemental calcium reduces cytotoxicity of the fecal
stream, which reinforces mucosal integrity. Additionally, calcium can protect
against diarrhea. Moreover, we have shown that dietary calcium reduces
intestinal permeability. An increased permeability is one of the major
characteristics of ulcerative colitis. Beneficial effects of calcium have been
shown in rats as well as humans. For example, calcium was protective in a rat
model of chronic intestinal inflammation. Although there are several
similarities between animals and humans, the question whether calcium is
beneficial for patients with ulcerative colitis can only be answered by doing
scientific research with patients.
Study objective
PRIMARY
• To investigate whether calcium supplementation, in addition to standard
induction therapy, decreases intestinal permeability (Chroom EDTA) in patients
with active ulcerative colitis.
• To observe whether calcium supplementation, in addition to standard induction
therapy, diminishes diarrhea (fecal dry weight) in patients with active
ulcerative colitis.
SECONDARY
• To evaluate whether calcium supplementation, in addition to standard
induction therapy, increases the percentage patients with a clinical response
and clinical remission at 2-4-6-9 and 12 weeks.
• To determine whether calcium supplementation, in addition to standard
induction therapy, decreases the percentage patients needing oral steroids.
• To determine whether calcium supplementation, in addition to standard
induction therapy, diminishes inflammatory activity as measured by inflammation
markers in blood and feces (fecal blood, calprotectin, mucins, and pancreatitis
associated protein (PAP)).
Study design
Randomized double-blind placebo controlled multicenter nutritional intervention
study
Intervention
Subjects will receive tablets with or without 500 mg calcium twice daily for 12
weeks.
Study burden and risks
Patients can maintain their habitual diet, except for some dairy products. At
the start of the study, patient need to fill in a short food frequency
questionnaire. Every measurement (week 0, 2, 4, 6, 9 and 12) patients need to
take a CrEDTA-capsule, and feces and urine are collected for the next 24h.
Blood will be taken at 3 visits (week 0, 6 and 12), when the patient will also
visit their physician. At these visit patients undergo a short physical
examination. Disease activity will be determined using a short scoring index
at every measurement (week 0, 2, 4, 6, 9 and 12). The visit, blood drawing
included, is part of standard therapy.
Nieuwe Kanaal 9a
6709 PA Wageningen
Nederland
Nieuwe Kanaal 9a
6709 PA Wageningen
Nederland
Listed location countries
Age
Inclusion criteria
•Patients between 18 and 70 years (inclusive) of age
•A diagnosis of UC, confirmed by conventional endoscopic and histological criteria
•Relapse documented by a SCCAI score boven 2.5
•Exacerbation can be first manifestation of disease or an exacerbation of known disease
•Patients must have tested negative for stool cultures including Clostridium difficile
•Patients who are capable of understanding the purpose and risks of the study and who provided a signed and dated written informed consent
Exclusion criteria
-UC requiring immediate surgical, or radiological interventions, including massive hemorrhage, perforation and sepsis, suppurative complications (intra-abdominal or peri-anal abscesses) or toxic colon
-investigator judgment that the subject is likely to require a colectomy within 12 weeks of baseline
-history of large bowel surgery or presence of a stoma
-presence or history of a fistula
-patients with serious infections
-significant organ dysfunction (serum creatinine >140 µmol/l, ALT/AST exceeding 3 times the ULN, platelets <100, white blood cells <2.5*109 cell/l)
-some concomitant medication (see protocol)
-pregnant women or nursing mothers
-patients with kidney stones or other illness possibly leading to hypercalceamia or hypercalciuria
-calcium supplement use and unwillingness to stop supplement intake 3 days prior to screening and during the intervention period
-unwillingness to partly restrict dairy intake during the intervention
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24265.042.08 |
| Other | volgt nog |