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Randomized, placebo-controlled trial of iron supplementation in infants with low hemoglobin levels fed iron-fortified formula.

In spite of the declining prevalence of iron-deficiency anemia, a large proportion of low-income infants have "low-normal" (11-11.5 g/dL) and "low" (less than 11 g/dL) hemoglobin (Hgb) values. Because most of these infants are fed iron-fortified formulas, it was of interest whether additional iron supplementation would enhance Hgb values. A cohort of 334 healthy, inner-city, minority, 6-month-old infants, fed iron-fortified formulas, with Hgb values ranging from 9 to 11.5 g/dL, participated in a double-blind, randomized, placebo-controlled trial of supplemental iron at 0, 3, and 6 mg/kg per day for 3 months. Hemoglobin values increased significantly with age, regardless of assignment to placebo or supplemental iron (means for the entire cohort: 6 months 10.9 g/dL, 8 months 11.2, 10 months 11.3, and 12 months 11.4). The proportion of "responders" (Hgb level increased greater than or equal to 1 g/dL) was 34% and did not differ significantly by placebo or iron dose. There were no significant differences in mean corpuscular volume or levels of erythrocyte porphyrins or serum ferritin between treatment groups. The implications of this clinical trial are twofold: (1) screening healthy infants fed iron-fortified formula at the age of 6 months is not justified, regardless of socioeconomic status; (2) the clinical practice of routinely treating low-income, "low-Hgb" infants with iron supplementation, without regard to dietary considerations, is unwarranted.

Anemia, Hypochromic↗

Oxygenation status of gynecologic tumors: what is the optimal hemoglobin level?

BACKGROUND: Tumor hypoxia has been linked to the development of treatment resistance, tumor progression, and poor prognosis. Since anemia is a major causative factor for the development of hypoxia, the association between blood hemoglobin concentration (cHb) and tumor oxygenation was examined in this study. PATIENTS AND METHODS: Pretreatment O(2) tension (pO(2)) measurements were performed in 59 primary carcinomas of the uterine cervix in which a stringent histopathologic examination of the electrode tracks was mandatory in order to exclude measurements in necrotic, stromal or normal cervical tissue. In addition, pO(2) readings in twelve primary cancers and 17 local recurrences of vulvar cancers were included in this study. cHb was determined at the time of pO(2) measurements. RESULTS: Data presented clearly show that an optimal Hb level with regard to the median pO(2) values of cervical and vulvar cancers should prevail at cHb values of between 12 and 14 g/dl (7.45-8.60 mmol/l). In anemic patients (cHb < 12 g/dl), the deterioration of the tumor oxygenation status can be explained by a reduced O(2) transport capacity. At cHb values > 14 g/dl, a worsening of the tumor oxygenation is apparent, most probably due to a drop in perfusion following a drastic increase in viscous resistance to flow. This pathogenetic mechanism is thought to counteract and finally to abrogate the high O(2) transport capacity in this cHb range. CONCLUSIONS: This study suggests that cHb values of between 12 and 14 g/dl are optimal with regard to the oxygenation status in the tumor entities investigated, a finding which may have far-reaching implications in the clinical setting.

Adult↗

Failure of D-thyroxine to increase fetal hemoglobin levels in normal and anemic baboons.

The synthesis of Hb F in baboons after erythropoietic stress is markedly increased. The mechanism of this "reverse switch" is unknown, but erythropoietin is not directly responsible for it. Since D-thyroxine has been reported to cause Hb F increases in marmosets, we determined its effect in normal and anemic baboons whose erythropoiesis, hemoglobin fractions and regulation of hemoglobin synthesis are similar to those of man. No effect was demonstrated in the normal baboons. In the anemic animal the Hb F level did not increase beyond the elevation attributable to the erythropoietic stress itself. It is therefore, unlikely that D-thyroxine will increase Hb F levels in man.

Anemia↗

Maintaining normal hemoglobin levels with epoetin alfa in mainly nonanemic patients with metastatic breast cancer receiving first-line chemotherapy: a survival study.

PURPOSE: To evaluate the effect on survival and quality of life of maintaining hemoglobin (Hb) in the range of 12 to 14 g/dL with epoetin alfa versus placebo in women with metastatic breast cancer (MBC) receiving first-line chemotherapy. PATIENTS AND METHODS: Eligible patients were randomly assigned to receive epoetin alfa 40,000 U once weekly or placebo for 12 months. Study drug was initiated if baseline Hb was < or = 13 g/dL or when Hb decreased to < or = 13g/dL during the study. The primary end point was 12-month overall survival (OS). RESULTS: The study drug administration was stopped early in accordance with a recommendation from the Independent Data Monitoring Committee because of higher mortality in the group treated with epoetin alfa. Enrollment had been completed, with 939 patients enrolled (epoetin alfa, n = 469; placebo, n = 470). Most patients had Hb more than 12 g/dL at baseline (median Hb, 12.8 g/dL) or during the study. From the final analysis, 12-month OS was 70% for epoetin alfa recipients and 76% for placebo recipients (P = .01). Optimal tumor response and time to disease progression were similar between groups. The reason for the difference in mortality between groups could not be determined from additional subsequent analyses involving both study data and chart review. CONCLUSION: In this trial, the use of epoetin alfa to maintain high Hb targets in women with MBC, most of whom did not have anemia at the start of treatment, was associated with decreased survival. Additional research is required to clarify the potential impact of erythropoietic agents on survival when the Hb target range is 10 to 12 g/dL.

Adult↗

The relationship of fetal plasma protein concentration and hemoglobin level to the development of hydrops in rhesus isoimmunization.

Fetoscopic samples of pure fetal blood were obtained at 18 to 25 weeks' gestation from seven hydropic and 10 nonhydropic fetuses affected by rhesus isoimmunization, and the fetal plasma albumin, plasma total protein, and hemoglobin concentrations were determined. All fetuses with sonographic evidence of hydrops had a hemoglobin of 3.8 gm/dl or less, whereas all but one of those without hydrops had a hemoglobin greater than 4.0 gm/dl. The plasma total protein was less than 2 standard deviations below the mean of the normal range in all hydropic fetuses and in six of 10 of those without hydrops. Hypoalbuminemia was found in six of the seven hydropic fetuses and in two of the nonhydropic fetuses. Ascitic fluid total protein and albumin concentrations were also determined in four hydropic fetuses, and the values in three were found to be more than 50% of the corresponding plasma levels.

Albumins↗