Low-dose ferrous bisglycinate chelate supplementation in chronic kidney disease and hemodialysis patients.
Study Goal
The researchers aimed to evaluate the efficiency and tolerability of a film-coated iron supplementation tablet containing ferrous bisglycinate chelate, vitamin C, and folic acid in CKD stage 3b to 4 and HD patients.
Results Summary
The study found that low-dose ferrous bisglycinate chelate improved serum iron concentration and transferrin saturation in CKD patients and maintained stable hemoglobin levels in HD patients, with no reported gastrointestinal adverse effects.
Population
Chronic kidney disease (CKD) stage 3b to 4 and hemodialysis (HD) patients.
Effective Dosage
Low-dose ferrous bisglycinate chelate (specific amount not provided).
Duration
16 weeks.
Interactions
None mentioned.
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
parenteral or oral iron supplementation | increase | iron stores and hemoglobin levels | chronic kidney disease (CKD) and hemodialysis (HD) patients | - | can restore iron stores and maintain stable hemoglobin levels | #1 |
IV iron | increase | iron stores | - | - | can restore iron stores rapidly | #2 |
IV iron | increase | allergy and infection | - | - | carries higher risks for allergy and infection | #3 |
Oral iron supplementation | increase | gastrointestinal adverse effects | - | - | is limited by high gastrointestinal adverse effects | #4 |
low-dose ferrous bisglycinate chelate | increase | serum iron concentration | stage 3 to 4 CKD patients | 67.8 vs 87.2 mg/dL | improved serum iron concentration | #5 |
low-dose ferrous bisglycinate chelate | increase | transferrin saturation | stage 3 to 4 CKD patients | 24.7% vs 31.3% | improved transferrin saturation | #6 |
low-dose ferrous bisglycinate chelate | decrease | iron loss | HD patients | - | restored iron loss | #7 |
low-dose ferrous bisglycinate chelate | no change | hemoglobin levels | HD patients | - | maintained stable hemoglobin levels | #8 |
film-coated iron supplementation tablet containing ferrous bisglycinate chelate, vitamin C, and folic acid | no change | GI upset events | CKD stage 3b to 4 and HD patients | - | No GI upset events were reported | #9 |
BACKGROUND: Provision of parenteral or oral iron supplementation can restore iron stores and maintain stable hemoglobin levels in chronic kidney disease (CKD) and hemodialysis (HD) patients. The route for oral or intravenous (IV) administration of iron depends on the acuity of anemia, costs, and patient tolerance. IV iron can restore iron stores rapidly but also carries higher risks for allergy and infection. Oral iron supplementation is limited by high gastrointestinal adverse effects. METHODS: We conducted an open-label trial to study the efficiency of a film-coated iron supplementation tablet, which contains ferrous bisglycinate chelate, vitamin C, and folic acid, in CKD stage 3b to 4 and HD patients. RESULTS: Twenty-seven HD patients and 20 CKD patients participated this study. After a 16-week intervention, low-dose ferrous bisglycinate chelate improved serum iron concentration (67.8 vs 87.2 mg/dL, p = 0.04) and transferrin saturation (24.7% vs 31.3%, p = 0.03) in stage 3 to 4 CKD patients, restored iron loss, and maintained stable hemoglobin levels in HD patients. No GI upset events were reported. CONCLUSION: Ferrous bisglycinate chelate is a well-tolerated oral iron supplementation for CKD and HD patients.