Iron Deficiency Clinical Trial
Official title:
Prospective Randomized Trial of Early Versus Late Enteral Iron Supplementation in Infants With a Birth Weight of Less Than 1301 Grams
Background: Preterm infants are at risk of iron deficiency. The smaller the infants are at
birth, the smaller the iron stores at birth and the higher the risk of iron deficiency.
Hypothesis: Preterm infants with a birth weight of less than 1301g require iron
supplementation earlier than previously recommended.
Methods: Prospective randomized controlled clinical trial (1996-1999). Results: Early iron
supplementation may reduce the incidence of iron deficiency and the need for late blood
transfusions.
Objectives. To examine whether early enteral iron supplementation (EI) would improve serum ferritin as a measure of nutritional iron status at 2 months of age and would prevent definite iron deficiency (ID) in infants with a birth weight of <1301 g. Methods. Infants were randomly assigned to receive enteral iron supplementation of 2 to 6 mg/kg/day as soon as enteral feedings of >100 mL/kg/day were tolerated (EI) or at 61 days of life (late enteral iron supplementation [LI]). Nutritional iron status was assessed: 1) at birth, 2) at 61 days of life, 3) when the infants reached a weight of 1.6 times birth weight, and 4) before blood was transfused at a hematocrit of <.25. ID was defined by any one of the following criteria: ferritin, <12 mg/L; transferrin saturation, <17%; or increase of absolute reticulocyte counts by >50% one week after the onset of enteral iron supplementation. Restrictive red cell transfusion guidelines were followed and all transfusions were documented. Erythropoietin was not administered. The primary outcome variables were: 1) ferritin at 61 days and 2) the number of infants with ID. Results. Ferritin at 61 days was not different between the groups. Infants in the LI group were more often iron-deficient (26/65 vs 10/68) and received more blood transfusions after day 14 of life. No adverse effects of EI were noted. Conclusions. EI is feasible and probably safe in infants with birth weight <1301 g. EI may reduce the incidence of ID and the number of late blood transfusions. ID may occur in very low birth weight infants despite early supplementation with iron and should be considered in the case of progressive anemia. Pediatrics 2000; 106:700 –706; preterm infant, iron supplementation, iron deficiency, blood transfusion. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01483768 -
Study of Sleeve Gastrectomy on Iron Intestinal Absorption in Morbidly Obese Patients
|
N/A | |
Completed |
NCT02888171 -
Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
|
N/A | |
Recruiting |
NCT02242188 -
Supplementing Iron and Development in Breastfed Infants (SIDBI Study)
|
Phase 4 | |
Completed |
NCT02714361 -
A Study to Investigate the Effect of Vitamin D3 Supplementation on Iron Status in Iron Deficient Women
|
N/A | |
Completed |
NCT02176759 -
Iron Absorption From Rice Fortified With Ferric Pyrophosphate
|
N/A | |
Completed |
NCT01922479 -
Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure
|
Phase 4 | |
Completed |
NCT01991626 -
Evaluation of the Effects of an Exogenous Phytase on Iron Absorption From LNS Added to Complementary Foods
|
N/A | |
Completed |
NCT01687062 -
Iron Absorption From Tef-injera in Women of Reproductive Age
|
N/A | |
Completed |
NCT01573013 -
Iron Fortification Trail Using NaFeEDTA in Iron Deficient Lead-exposed Children
|
N/A | |
Completed |
NCT01443832 -
Iron Absorption From Iron-fortified Fonio Porridge: a Stable Isotope Study
|
Phase 0 | |
Completed |
NCT01191463 -
The Efficacy of a Local Vitamin-C Rich Fruit (Guava) in Improving Iron Absorption From Mungbean Based Meals and Its Effect on Iron Status of Rural Indian Children (6-10 Years)
|
N/A | |
Completed |
NCT01061307 -
An Efficacy Trial of Iron, Zinc and Vitamin A Fortified Rice in Children in Satun, Thailand
|
Phase 0 | |
Not yet recruiting |
NCT00515918 -
The Effect of Early Iron Deficiency on Developmental Brain and Behavior in Infants
|
N/A | |
Recruiting |
NCT00378469 -
Study of the Effects of Muscular Activity on Iron Metabolism
|
N/A | |
Recruiting |
NCT05992116 -
Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction
|
||
Completed |
NCT05262634 -
Pregnancy Outcome in Women With an Iron Deficiency in the First Trimester
|
||
Completed |
NCT06080555 -
Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia
|
Phase 1 | |
Completed |
NCT04602247 -
Evaluation of Iron Bioavailability From Iron Chlorophyllin
|
N/A | |
Completed |
NCT02996786 -
Effects of Danggui Buxue Tang on Blood Biochemical Parameters in Male Recreational Runners
|
N/A | |
Completed |
NCT02175888 -
The Optimization of Bioavailability From Iron Supplements: Study 1
|
N/A |