Daily and Weekly Iron Supplementations to Improve Iron Status in Infants: A Randomized Controlled Trial

Background: Iron deficiency anemia screening and iron supplementation in infants aged 6 to12 months are recommended in the Guideline in Child Health Supervision. Objective: To evaluate the effectiveness of weekly iron supplementation compared with daily supplementation in improving the iron status in infants. Materials and Methods: A single-blind randomized controlled trial was conducted in infants aged 6 months visiting the Well Child Clinic between May 2019 and November 2020 at Burapha University Hospital, Chonburi, Thailand. The intervention consisted of either daily or weekly iron supplementation combined with iron-rich complementary food promotion for six months. The outcomes were the differences of serum ferritin and hematological variables before and after being iron supplemented. Results: Sixty-nine of the six-month-old healthy infants were randomized to receive either 10 mg Fe/day as the daily group or 30 mg Fe/week as the weekly group. Forty-five infants with 24 in the daily group and 21 in the weekly group completed the intervention. After the six-month period of iron supplementation, the average differences of serum ferritin in the daily and the weekly group were 10.85 (–13.19, 34.49) and –9.31 (–23.86, –2.30) ng/mL, respectively (p=0.012). The average differences of hemoglobin in the daily and the weekly group were 0.58±0.82 and 0.08±0.59 g/dL, respectively (95% CI 0.06 to 0.93; p=0.026). Conclusion: Daily iron supplementation of 10 mg/day is more effective than 30 mg weekly iron supplementation in improving iron status and hemoglobin level in the Thai infants. Keywords: Anemia; Ferritin; Infants; Iron deficiency; Iron supplementation

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A Randomized Controlled Trial of Daily and Weekly Iron Supplementations for Improving Iron Status in the Infants

10.21203/rs.3.rs-310880/v1 ◽

2021 ◽

Author(s):

Nalinee Pattrakornkul ◽

Parichaya Ngamcherdtrakul ◽

Warawut Kriangburapa ◽

Siriporn Tangjaturonrasme ◽

Ramorn Yampratoom

Keyword(s):

Randomized Controlled Trial ◽

Iron Deficiency ◽

Iron Supplementation ◽

Iron Status ◽

Controlled Trial ◽

Daily Group ◽

Randomized Controlled ◽

The Mean ◽

Mean Differences ◽

Weekly Group

Abstract Background: Iron deficiency anemia screening and iron supplementation in infants aged 6-12 months are recommended in the Guideline in Child Health Supervision. This study aims to evaluate the effectiveness of weekly iron supplementation compared with daily supplementation in improving the iron status in infants.Methods: A single-blind randomized controlled trial was conducted in infants aged 6 months visiting the Well Child Clinic between May 2019 and November 2020 at Burapha University Hospital, Chonburi, Thailand. The intervention consisted of either daily or weekly iron supplementation combined with iron-rich complementary food promotion for six months. The outcomes were the differences of serum ferritin and hematological variables before and after being iron supplemented. Results: Sixty-nine six-month-old healthy infants were randomized to receive either 10 mg Fe/day (daily group) or 30 mg Fe/week (weekly group). Forty-five infants (daily group; n = 24 and weekly group; n = 21) completed the intervention. After the six-month period of iron supplementation, the mean differences of serum ferritin in the daily and the weekly group were 8.78±37.21 and -13.05 ±17.53 ng/mL, respectively (95%CI: 4.54, 39.12; P=0.015). The mean differences of hemoglobin in the daily and the weekly group were 0.58±0.82 and 0.08±0.59 g/dL, respectively (95%CI: 0.06, 0.93; P=0.026). Daily supplementation could prevent iron deficiency more than weekly supplementation significantly (P=0.029), particularly in the exclusive breastfeeding subgroup (P=0.032).Conclusions: Daily iron supplementation is more effective than weekly iron supplementation in improving iron status and hemoglobin level in infants, especially in the exclusively breast-feds.Trial registration: TCTR20191107001, November 7th, 2019. Retrospectively registered, http://www.thaiclinicaltrials.org

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Intravenous versus Oral iron for Iron-Deficiency Anemia in Pregnancy (IVIDA): A Randomized Controlled Trial

American Journal of Perinatology ◽

10.1055/s-0041-1740003 ◽

2021 ◽

Author(s):

Adam K. Lewkowitz ◽

Molly J. Stout ◽

Emily Cooke ◽

Seon C. Deoni ◽

Viren D'Sa ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Iron Deficiency ◽

Iron Deficiency Anemia ◽

Adverse Reactions ◽

Controlled Trial ◽

Oral Iron ◽

Deficiency Anemia ◽

Randomized Controlled ◽

Iv Iron ◽

Severe Adverse Reactions

Objective Iron-deficiency anemia (IDA) can have serious consequences for mothers and babies. Iron supplementation is recommended, but the administration route is controversial. We sought to conduct a randomized controlled trial (RCT) testing the effectiveness and safety of intravenous (IV) iron compared with oral iron on perinatal outcomes in pregnant women with IDA. Study Design This open-label RCT randomized patients with IDA (hemoglobin [hgb] <10 g/dL and ferritin <30 ng/mL) at 24 to 34 weeks' to oral iron or single 1,000-mg dose of IV low-molecular weight iron dextran over one hour. The primary outcome was maternal anemia at delivery (hgb < 11 g/dL). Secondary outcomes were mild/moderate or severe adverse reactions, maternal hgb and ferritin at delivery, blood transfusion, gestational age at delivery, birth weight, neonatal hgb and ferritin, and composite neonatal morbidity. Analysis was as per protocol. Results The trial was stopped early for logistical reasons, and the data analyzed as preliminary data to inform a larger, potentially externally funded, definitive trial. Of 55 patients approached, 38 consented. Of these, 15 were withdrawn: 5 received IV iron from their primary obstetrician after being randomized to oral iron and 10 declined to receive IV iron. Of the remaining 23 patients, who were included in the analytic population, 13 received oral iron and 10 received IV iron. The rate of maternal anemia at delivery (hgb < 11 g/dL) was high overall but significantly reduced with IV iron (40 vs. 85%, p = 0.039). Rates of maternal hgb < 10 g/dL were significantly lower in the IV iron group (10 vs. 54%, p = 0.029). There were no severe adverse reactions and similar rates of mild/moderate reactions between groups. Conclusion IV iron reduces rates of anemia at the time of admission for delivery, supporting a larger RCT comparing IV versus oral iron for the treatment of IDA of pregnancy powered for definitive clinical outcomes. However, issues uncovered in this RCT suggest that patient, clinician, and systems-level barriers associated with different IDA treatment modalities must be considered prior to conducting a larger RCT. This study is registered with clinicaltrials.gov with identifier no.: NCT03438227. Key Points

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