Randomized, Controlled Trial of Single Versus 3-Times-Daily Ferrous Sulfate Drops for Treatment of Anemia

Zlotkin, Stanley; Arthur, Paul; Antwi, Kojo Yeboah; Yeung, George

doi:10.1542/peds.108.3.613

Cited by 65 publications

(62 citation statements)

References 19 publications

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“…12 In this trial, a daily iron dose at the lower end of the recommended range (3 mg/kg of elemental iron) administered just once daily, at bedtime, and on an empty stomach was chosen. Two prior randomized clinical trials in children 10,11 informed this minimalist strategy aimed to en- Studies involving adults with IDA also support the use of low-dose oral iron treatment. In 1 trial, 14 octogenarians with anemia were randomized to 15 mg, 50 mg, or 150 mg of ferrous salts (gluconate or citrate) administered once daily and had virtually identical hematologic responses, but there were far less gastrointestinal toxic effects in the group receiving 15 mg. A study in women with iron deficiency using stable iron isotopes demonstrated that a single dose of iron engendered a prompt increase in serum hepcidin level that resulted in markedly reduced absorption of subsequent iron doses 12 hours or even 24 hours later.…”

Section: Discussionmentioning

confidence: 99%

Effect of Low-Dose Ferrous Sulfate vs Iron Polysaccharide Complex on Hemoglobin Concentration in Young Children With Nutritional Iron-Deficiency Anemia

Powers

Buchanan

Adix³

et al. 2017

JAMA

102

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IMPORTANCE Iron-deficiency anemia (IDA) affects millions of persons worldwide, and is associated with impaired neurodevelopment in infants and children. Ferrous sulfate is the most commonly prescribed oral iron despite iron polysaccharide complex possibly being better tolerated.OBJECTIVE To compare the effect of ferrous sulfate with iron polysaccharide complex on hemoglobin concentration in infants and children with nutritional IDA. DESIGN, SETTING, AND PARTICIPANTS Double-blind, superiority randomized clinical trial of infants and children aged 9 to 48 months with nutritional IDA (assessed by history and laboratory criteria) that was conducted in an outpatient hematology clinic at a US tertiary care hospital from September 2013 through November 2015; 12-week follow-up ended in January 2016.INTERVENTIONS Three mg/kg of elemental iron once daily as either ferrous sulfate drops or iron polysaccharide complex drops for 12 weeks. MAIN OUTCOMES AND MEASURESPrimary outcome was change in hemoglobin over 12 weeks. Secondary outcomes included complete resolution of IDA (defined as hemoglobin concentration >11 g/dL, mean corpuscular volume >70 fL, reticulocyte hemoglobin equivalent >25 pg, serum ferritin level >15 ng/mL, and total iron-binding capacity <425 μg/dL at the 12-week visit), changes in serum ferritin level and total iron-binding capacity, adverse effects. RESULTSOf 80 randomized infants and children (median age, 22 months; 55% male; 61% Hispanic white; 40 per group), 59 completed the trial (28 [70%] in ferrous sulfate group; 31 [78%] in iron polysaccharide complex group). From baseline to 12 weeks, mean hemoglobin increased from 7.9 to 11.9 g/dL (ferrous sulfate group) vs 7.7 to 11.1 g/dL (iron complex group), a greater difference of 1.0 g/dL (95% CI, 0.4 to 1.6 g/dL; P < .001) with ferrous sulfate (based on a linear mixed model). Proportion with a complete resolution of IDA was higher in the ferrous sulfate group (29% vs 6%; P = .04). Median serum ferritin level increased from 3.0 to 15.6 ng/mL (ferrous sulfate) vs 2.0 to 7.5 ng/mL (iron complex) over 12 weeks, a greater difference of 10.2 ng/mL (95% CI, 6.2 to 14.1 ng/mL; P < .001) with ferrous sulfate. Mean total iron-binding capacity decreased from 501 to 389 μg/dL (ferrous sulfate) vs 506 to 417 μg/dL (iron complex) (a greater difference of −50 μg/dL [95% CI, −86 to −14 μg/dL] with ferrous sulfate; P < .001). There were more reports of diarrhea in the iron complex group than in the ferrous sulfate group (58% vs 35%, respectively; P = .04).CONCLUSIONS AND RELEVANCE Among infants and children aged 9 to 48 months with nutritional iron-deficiency anemia, ferrous sulfate compared with iron polysaccharide complex resulted in a greater increase in hemoglobin concentration at 12 weeks. Once daily, low-dose ferrous sulfate should be considered for children with nutritional iron-deficiency anemia.

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Section: Discussionmentioning

confidence: 99%

Effect of Low-Dose Ferrous Sulfate vs Iron Polysaccharide Complex on Hemoglobin Concentration in Young Children With Nutritional Iron-Deficiency Anemia

Powers

Buchanan

Adix³

et al. 2017

JAMA

102

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“…Our goal for these studies was to evaluate the efficacy and acceptability of Sprinkles in controlled settings, and to describe the absorption of iron from Sprinkles. In collaboration with the Ghanaian Ministry of Health, Kintampo Health Research Centre, our first RCT demonstrated that in anemic infants, Sprinkles achieved a rate of cure similar to that of the reference standard, iron drops (6)(7)(8). Approximately 60% of infants went from an anemic to a non-anemic state in two months, which is a successful outcome in a malaria-endemic area.…”

Section: Evaluation Of Sprinklesmentioning

confidence: 83%

A New Approach to Control of Anemia in “At Risk” Infants and Children Around the World 2004 Ryley-Jeffs Memorial Lecture

Zlotkin

2004

Canadian Journal of Dietetic Practice and Research

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An estimated 60-80% of the world's population is affected by iron deficiency. It is the most common preventable nutritional deficiency in the world, despite global goals for its reduction. Young children are the highest risk group, particularly during their rapid period of growth. Anemia in infants and young children is known to have a negative impact on motor and socioemotional development and cognitive function. A new intervention, microencapsulated ferrous fumarate Sprinkles, has been developed to treat iron deficiency. The development process took the intervention from the idea stage to the research stage to the implementation stage. Multiple micronutrient Sprinkles are a breakthrough in meeting the global challenge to reduce childhood anemia due to iron and other micronutrient deficiencies. The goal of the Sprinkles project is to reduce the global burden of childhood anemia by promoting healthy weaning practices, by advocating home-fortification strategies to increase the micronutrient content of weaning foods, and by making Sprinkles widely available, particularly in developing countries.

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“…[29][30][31] Modified-release preparations of iron are licensed for once-daily dosage, but have no proven therapeutic advantage over conventional formulations. Contrary to some reports, 28 meta-analysis suggests that they are no better tolerated than standard formulations.…”

Section: Monitoring Of Responsementioning

confidence: 99%

“…28 Despite the lack of supportive meta-analytic data, 19 a dose reduction is sometimes effective and, because of the saturability of intestinal iron absorption, can be equally efficacious in replenishing iron stores. [29][30][31] Modified-release preparations of iron are licensed for once-daily dosage, but have no proven therapeutic advantage over conventional formulations. Contrary to some reports, 28 meta-analysis suggests that they are no better tolerated than standard formulations.…”

Section: Monitoring Of Responsementioning

confidence: 99%

Treatment of iron deficiency anemia: practical considerations

Taylor¹,

Rampton²

2015

Polish Archives of Internal Medicine

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The aims of this article, which is directed primarily at generalists, are to outline the relevant features of iron metabolism, to summarize the indications for treatment of IDA, and to compare the advantages and disadvantages of treatment with oral and intravenous iron. We shall then focus particularly on practical aspects of treatment with iron. Topics which we shall not cover include investigation of the cause of IDA (for guidance, see Goddard et al 3 ) and use of blood transfusion. We shall also omit the mention of therapy with erythropoietin, as this is a specialist treatment restricted primarily to patients with chronic kidney disease or having cancer chemotherapy.Iron metabolism As a background to our focus on the management of IDA, we provide below a brief overview of iron metabolism (for a comprehensive recent review, see Waldvogel-Abramowski et al 7 ).Iron absorption and turnover The human body contains from 30 to 40 mg/kg body weight of iron. It is mostly contained in hemoglobin (Hb), ferritin, and other heme and nonheme proteins. Iron is an essential element, being a constituent of a range of enzymes involved in redox reactions and oxygen delivery. Red blood cells have the highest demand for iron of all cells.Introduction Anemia is common in all populations worldwide and is frequently caused by iron deficiency. In developed countries, the prevalence of iron deficiency anemia (IDA) is from 2% to 5% in adult men and postmenopausal women and about 10% in women of child-bearing age; it is much more common in hospitalized patients. [1][2][3] Iron deficiency occurs when iron losses exceed its intestinal absorption. This happens in patients with decreased iron intake, malabsorption of iron, increased demand for iron, or through ongoing iron loss. In the Western world, while IDA is often multifactorial, menstruation is the most common single cause. Reduced dietary intake of iron (vegetarians and the elderly being particularly at risk), bleeding from the gastrointestinal tract (for example, due to neoplasia or use of aspirin or nonsteroidal anti-inflammatory drugs), malabsorption (particularly in celiac disease), pregnancy, and blood donation are other frequent causes. 3,4 IDA is associated with worsened quality of life, impaired physical and cognitive performance, 2,5 and in hospitalized patients, longer length of hospital stay and poorer clinical outcomes. 1,6 It also increases the likelihood of patients receiving blood transfusions with their attendant risks.1 Therefore, effective treatment of patients with IDA is extremely worthwhile. Key wordsanemia, intravenous iron, iron deficiency, hypersensitivity reactions, oral iron AbstrActIron deficiency anemia is a common problem worldwide, and doctors of all specialties need to be competent in its treatment. While most patients respond well to oral iron preparations, a substantial minority have side effects that make them adhere poorly to their treatment. For oral iron-intolerant patients, those responding poorly despite good adherence, and those with severe...

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Randomized, Controlled Trial of Single Versus 3-Times-Daily Ferrous Sulfate Drops for Treatment of Anemia

Cited by 65 publications

References 19 publications

Effect of Low-Dose Ferrous Sulfate vs Iron Polysaccharide Complex on Hemoglobin Concentration in Young Children With Nutritional Iron-Deficiency Anemia

Effect of Low-Dose Ferrous Sulfate vs Iron Polysaccharide Complex on Hemoglobin Concentration in Young Children With Nutritional Iron-Deficiency Anemia

A New Approach to Control of Anemia in “At Risk” Infants and Children Around the World 2004 Ryley-Jeffs Memorial Lecture

Treatment of iron deficiency anemia: practical considerations

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