Iron Deficiency Anemia After Weight Loss Surgery
Conditions
Interventions
Intervention Group:Iron isomaltoside injection (MonoFer), administered by intravenous drip, referring to the simplified scale method of administration in the product insert. Note: The maximum single d
Control Group:Iron Polysaccharide Complex (NIFEREX), 150mg/day for 8 weeks by oral
Sponsors
The Third People's Hospital of Chengdu
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-60, six months after weight loss surgery, BMI 6g/dl and =12g/dl; Females: Hb >6g/dl and =11g/dl, and patients who do not require blood transfusion (3) SF <30ng/ml, or SF<100ng/ml combined with TSAT <20% (4) Signed informed consent form
Exclusion criteria
Exclusion criteria: (1) Women who are pregnant, breastfeeding or planning to become pregnant (2) Those with hypersensitivity reactions to active ingredients, iron isomaltoside injection and any excipients (3) Known severe hypersensitivity reactions to other parenteral iron products (4) Non-iron deficiency anemia (such as hemolytic anemia, megaloblastic anemia) (5) Iron overload or disorders of iron utilization (such as siderosis, hemosiderosis, thalassemia etc.) (6) Decompensated cirrhosis or active hepatitis (alanine aminotransferase > 3 times the upper limit of normal) (7) Coexisting chronic gastrointestinal diseases (like inflammatory bowel disease, ulcerative colitis etc.) (8) Coexisting chronic kidney disease (9) Acute altitude sickness (10) Women of childbearing age with excessive menstrual bleeding (>80ml) (11)Literacy impaired individuals (12) History of smoking (13 )Ultrasound showing presence of gallstones (14)Bone marrow disorders and blood system disorders(acquired abnormalities in hemoglobin or coagulation disorder) (15)Major incision bleeding situations requiring drainage surgery for massive perioperative bleeding , shock or hematoma formation. (16)Acute infection or C-reactive protein concentration greater than 5 mg/L. (17)Vitamin B12 concentration less than 210 pg/mL; Folate concentration less than 3.3 ng/mL; Albumin concentration less than 3 g/dL.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with Hb elevation =2g/dl; | — |
Secondary
| Measure | Time frame |
|---|---|
| serum ferritin;Transferrin saturation;FACIT score;Short-Form 12; | — |
Countries
China
Contacts
Public ContactYnajun Liu
The Third People's Hospital of Chengdu
Outcome results
None listed