Effects of oral iron supplementation on the gut microbiome and plasma uremic toxin levels in patients with chronic kidney disease
- Conditions
- Iron deficiency in CKD1002295810038430
- Registration Number
- NL-OMON41855
- Lead Sponsor
- aboratoriumgeneeskunde
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 6
1. Age range: 18-80 years
2. CKD stage III-IV (GFR of 15-60 ml/min /1.73m2)
3. Iron deficient and an indication for treatment with ferrous fumarate, that is Hb < 7 mmol/L, TSAT (transferrin saturation) <20% and ferritin < 200 µg/l, in the presence of a CRP < 10 mg/L).
4. Living in the region of Nijmegen, that is within 20 km from Radboudumc
1. Patients already under treatment with iron (orally or intravenously), or finished iron treatment <= 4 weeks before start of the trial.
2. Patients using over the counter iron supplements / iron fortified products
3. Constipation (defecation less than 3 times a week).
4. Treatment with antibiotics <= 4 weeks before start the trial. If antibiotic treatment is required during the trial, patients are excluded from the trial.
5. Start of Sevelamer treatment during the trial (patients already on Sevelamer treatment and which is continued do not have to be excluded).
6. Hb < 4.5
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Blood uremic toxin levels (13 uremic toxins: hippurate, indoles (indoxyl<br /><br>sulfate, indoxyl glucuronide and indole-3-acetic acid, tryptophan metabolites<br /><br>(kynurenine, kynureninic acid and quinolinic acid), phenols (phenyl acetic<br /><br>acid, phenyl sulphate, phenyl glucuronide,<br /><br>3-carboxy-4-methyl-5-propyl-2-furanpropionic acid (CMPF), p-cresyl sulfate and<br /><br>p-cresyl glucuronide), before, during, and after iron treatment.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• Faecal uremic toxin levels (13 uremic toxins; see above), before, during, and<br /><br>after iron treatment<br /><br>• Gut microbiome composition, before, during, and after iron treatment<br /><br>• Gut microbial proteolytic activity by faecal ammonia, before, during, and<br /><br>after iron treatment<br /><br>• Blood ammonia levels, before, during, and after iron treatment<br /><br>• Faecal iron content (for correlation with the gut microbiome composition)<br /><br>• Other blood parameters: Hb (hemoglobin), MCV (Mean Corpuscular Volume), Fe,<br /><br>TIBC (Total iron binding capacity), ferritin, CRP (C-reactive protein),<br /><br>creatinine (estimation GFR).<br /><br>o The transferrin saturation will be calculated based on TIBC and Fe.</p><br>