scholarly journals Safe and effective delivery of supplemental iron to healthy older adults: The double-blind, randomized, placebo-controlled trial protocol of the Safe Iron Study

2021 ◽  
Vol 3 ◽  
pp. 1510
Author(s):  
Erin D. Lewis ◽  
Dayong Wu ◽  
Joel B. Mason ◽  
Athar H. Chishti ◽  
John M. Leong ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Adverse Effects ◽  
Phase I ◽  
Ex Vivo ◽  
Iron Status ◽  
Controlled Trial ◽  
Double Blind ◽  
Sulfate Heptahydrate ◽  
Bacterial Proliferation ◽  
Forms Of Iron

The forms of iron currently available to correct iron deficiency have adverse effects, including infectious diarrhea, increased susceptibility to malaria, inflammation and detrimental changes to the gut microbiome. These adverse effects limit their use such that the growing burden of iron deficiency has not abated in recent decades. Here, we summarize the protocol of the “Safe Iron Study”, the first clinical study examining the safety and efficacy of novel forms of iron in healthy, iron-replete adults. The Safe Iron Study is a double-blind, randomized, placebo-controlled trial conducted in Boston, MA, USA. This study compares ferrous sulfate heptahydrate (FeSO4·H2O) with two novel forms of iron supplements (iron hydroxide adipate tartrate (IHAT) and organic fungal iron metabolite (Aspiron™ Natural Koji Iron)). In Phase I, we will compare each source of iron administrated at a low dose (60 mg Fe/day). We will also determine the effect of FeSO4 co-administrated with a multiple micronutrient powder and weekly administration of FeSO4. The forms of iron found to produce no adverse effects, or adverse effects no greater than FeSO4 in Phase I, Phase II will evaluate a higher, i.e., a therapeutic dose (120 mg Fe/day). The primary outcomes of this study include ex vivo malaria (Plasmodium falciparum) infectivity of host erythrocytes, ex vivo bacterial proliferation (of selected species) in presence of host plasma and intestinal inflammation assessed by fecal calprotectin. This study will test the hypotheses that the novel forms of iron, administered at equivalent doses to FeSO4, will produce similar increases in iron status in iron-replete subjects, yet lower increases in ex vivo malaria infectivity, ex vivo bacterial proliferation, gut inflammation. Ultimately, this study seeks to contribute to development of safe and effective forms of supplemental iron to address the global burden of iron deficiency and anemia. Registration: ClinicalTrials.gov identifier: NCT03212677; registered: 11 July 2017.

scholarly journals Safe and effective delivery of supplemental iron to healthy older adults: The double-blind, randomized, placebo-controlled trial protocol of the Safe Iron Study

2019 ◽  
Vol 3 ◽  
pp. 1510
Author(s):  
Erin D. Lewis ◽  
Dayong Wu ◽  
Joel B. Mason ◽  
Athar H. Chishti ◽  
John M. Leong ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Adverse Effects ◽  
Phase I ◽  
Ex Vivo ◽  
Iron Status ◽  
Controlled Trial ◽  
Double Blind ◽  
Sulfate Heptahydrate ◽  
Bacterial Proliferation ◽  
Forms Of Iron

The forms of iron currently available to correct iron deficiency have adverse effects, including infectious diarrhea, increased susceptibility to malaria, inflammation and detrimental changes to the gut microbiome. These adverse effects limit their use such that the growing burden of iron deficiency has not abated in recent decades. Here, we summarize the protocol of the “Safe Iron Study”, the first clinical study examining the safety and efficacy of novel forms of iron in healthy, iron-replete adults. The Safe Iron Study is a double-blind, randomized, placebo-controlled trial conducted in Boston, MA, USA. This study compares ferrous sulfate heptahydrate (FeSO4·H2O) with two novel forms of iron supplements (iron hydroxide adipate tartrate (IHAT) and organic fungal iron metabolite (Aspiron™ Natural Koji Iron)). In Phase I, we will compare each source of iron administrated at a low dose (60 mg Fe/day). We will also determine the effect of FeSO4 co-administrated with a multiple micronutrient powder and weekly administration of FeSO4. The forms of iron found to produce no adverse effects or adverse effects no greater than FeSO4 in Phase I, Phase II will evaluate a higher, i.e., a therapeutic dose (120 mg Fe/day). The primary outcomes of this study include ex vivo malaria (Plasmodium falciparum) infectivity of host erythrocytes, ex vivo bacterial proliferation (of selected species) in presence of host plasma and intestinal inflammation assessed by fecal calprotectin. This study will test the hypotheses that the novel forms of iron, administered at equivalent doses to FeSO4, will produce similar increases in iron status in iron-replete subjects, yet lower increases in ex vivo malaria infectivity, ex vivo bacterial proliferation, gut inflammation. Ultimately, this study seeks to contribute to development of safe and effective forms of supplemental iron to address the global burden of iron deficiency and anemia. Registration: ClinicalTrials.gov identifier: NCT03212677; registered: 11 July 2017.

scholarly journals Consumption of a Double-Fortified Salt Affects Perceptual, Attentional, and Mnemonic Functioning in Women in a Randomized Controlled Trial in India

2017 ◽  
Vol 147 (12) ◽  
pp. 2297-2308 ◽  
Author(s):  
Michael J Wenger ◽  
Laura E Murray-Kolb ◽  
Julie EH Nevins ◽  
Sudha Venkatramanan ◽  
Gregory A Reinhart ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Iron Status ◽  
Controlled Trial ◽  
Reproductive Age ◽  
Deficiency Anemia ◽  
Control Group ◽  
Attention And Memory ◽  
Double Blind ◽  
Iron Deficient ◽  
Mnemonic Function

Abstract Background: Iron deficiency and iron deficiency anemia have been shown to have negative effects on aspects of perception, attention, and memory. Objective: The purpose of this investigation was to assess the extent to which increases in dietary iron consumption are related to improvements in behavioral measures of perceptual, attentional, and mnemonic function. Methods: Women were selected from a randomized, double-blind, controlled food-fortification trial involving ad libitum consumption of either a double-fortified salt (DFS) containing 47 mg potassium iodate/kg and 3.3 mg microencapsulated ferrous fumarate/g (1.1 mg elemental Fe/g) or a control iodized salt. Participants' blood iron status (primary outcomes) and cognitive functioning (secondary outcomes) were assessed at baseline and after 10 mo at endline. The study was performed on a tea plantation in the Darjeeling district of India. Participants (n = 126; 66% iron deficient and 49% anemic at baseline) were otherwise healthy women of reproductive age, 18–55 y. Results: Significant improvements were documented for iron status and for perceptual, attentional, and mnemonic function in the DFS group (percentage of variance accounted for: 16.5%) compared with the control group. In addition, the amount of change in perceptual and cognitive performance was significantly (P < 0.05) related to the amount of change in blood iron markers (mean percentage of variance accounted for: 16.0%) and baseline concentrations of blood iron markers (mean percentage of variance accounted for: 25.0%). Overall, there was evidence that the strongest effects of change in iron status were obtained for perceptual and low-level attentional function. Conclusion: DFS produced measurable and significant improvements in the perceptual, attentional, and mnemonic performance of Indian female tea pickers of reproductive age. This trial was registered at clinicaltrials.gov as NCT01032005.

scholarly journals Reducing Iron Content in Infant Formula from 8 to 2 mg/L Does Not Increase the Risk of Iron Deficiency at 4 or 6 Months of Age: A Randomized Controlled Trial

Nutrients ◽  
2020 ◽  
Vol 13 (1) ◽  
pp. 3
Author(s):  
Maria Björmsjö ◽  
Olle Hernell ◽  
Bo Lönnerdal ◽  
Staffan K. Berglund
Keyword(s):  
Breast Milk ◽  
Iron Deficiency ◽  
Infant Formula ◽  
Iron Content ◽  
Iron Status ◽  
Controlled Trial ◽  
Bovine Lactoferrin ◽  
High Concentration ◽  
Double Blind ◽  
Term Infants

Many infant formulas are fortified with iron at 8–14 mg/L whereas breast milk contains about 0.3 mg/L. Another major difference between breast milk and infant formula is its high concentration of lactoferrin, a bioactive iron-binding protein. The aim of the present study was to investigate how reducing the iron content and adding bovine lactoferrin to infant formula affects iron status, health and development. Swedish healthy full-term formula-fed infants (n = 180) were randomized in a double-blind controlled trial. From 6 weeks to 6 months of age, 72 infants received low-iron formula (2 mg/L) fortified with bovine lactoferrin (1.0 g/L) (Lf+), 72 received low-iron formula un-fortified with lactoferrin (Lf−) and 36 received standard formula with 8 mg of iron/L and no lactoferrin fortification as controls (CF). Iron status and prevalence of iron deficiency (ID) were assessed at 4 and 6 months. All iron status indicators were unaffected by lactoferrin. At 4 and 6 months, the geometric means of ferritin for the combined low-iron groups compared to the CF-group were 67.7 vs. 88.7 and 39.5 vs. 50.9 µg/L, respectively (p = 0.054 and p = 0.056). No significant differences were found for other iron status indicators. In the low-iron group only one infant (0.7%) at 4 months and none at 6 months developed ID. Conclusion: Iron fortification of 2 mg/L is an adequate level during the first half of infancy for healthy term infants in a well-nourished population. Adding lactoferrin does not affect iron status.

scholarly journals A novel nano-iron supplement to safely combat iron deficiency and anaemia in young children: The IHAT-GUT double-blind, randomised, placebo-controlled trial protocol

2018 ◽  
Vol 2 ◽  
pp. 48 ◽  
Author(s):  
Dora I.A. Pereira ◽  
Nuredin I. Mohammed ◽  
Ogochukwu Ofordile ◽  
Famalang Camara ◽  
Bakary Baldeh ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Young Children ◽  
Adverse Effects ◽  
Intestinal Inflammation ◽  
Controlled Trial ◽  
Iron Hydroxide ◽  
Ferrous Sulphate ◽  
Iron Supplement ◽  
Double Blind ◽  
Poor Countries

Background: Iron deficiency and its associated anaemia (IDA) are the leading forms of micronutrient malnutrition worldwide. Here we describe the rationale and design of the first clinical trial evaluating the efficacy and safety of an innovative nano iron supplement, iron hydroxide adipate tartrate (IHAT), for the treatment of IDA in young children (IHAT-GUT trial). Oral iron is often ineffective due to poor absorption and/or gastrointestinal adverse effects. IHAT is novel since it is effectively absorbed whilst remaining nanoparticulate in the gut, therefore should enable supplementation with fewer symptoms. Methods: IHAT-GUT is a three-arm, double-blind, randomised, placebo-controlled phase II trial conducted in Gambian children 6-35 months of age. The intervention consists of a 12-week supplementation with either IHAT, ferrous sulphate (both at doses bioequivalent to 12.5 mg Fe/day) or placebo. The trial aims to include 705 children with IDA who will be randomly assigned (1:1:1) to each arm. The primary objectives are to test non-inferiority of IHAT in relation to ferrous sulphate at treating IDA, and to test superiority of IHAT in relation to ferrous sulphate and non-inferiority in relation to placebo in terms of diarrhoea incidence and prevalence. Secondary objectives are mechanistic assessments, to test whether IHAT reduces the burden of enteric pathogens, morbidity, and intestinal inflammation, and that it does not cause detrimental changes to the gut microbiome, particularly in relation to Lactobacillaceae, Bifidobacteriaceae and Enterobacteriaceae. Discussion: This trial will test the hypothesis that supplementation with IHAT eliminates iron deficiency and improves haemoglobin levels without inducing gastrointestinal adverse effects. If shown to be the case, this would open the possibility for further testing and use of IHAT as a novel iron source for micronutrient intervention strategies in resource-poor countries, with the ultimate aim to help reduce the IDA global burden. Registration: This trial is registered at clinicaltrials.gov (NCT02941081).

scholarly journals A Community Trial Examining the Effectiveness of Iron-fortified Lentils to Improve Iron Status Among Bangladeshi Adolescent Girls: Results from a Baseline Survey (P10-099-19)

2019 ◽  
Vol 3 (Supplement_1) ◽  
Author(s):  
Fakir Yunus ◽  
Anupom Das ◽  
Chowdhury Jalal ◽  
Kaosar Afsana ◽  
Rajib Podder ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Serum Ferritin ◽  
Adolescent Girls ◽  
Iron Status ◽  
Controlled Trial ◽  
Baseline Data ◽  
Health Concern ◽  
Baseline Survey ◽  
Double Blind ◽  
Status Survey

Abstract Objectives Despite all efforts, iron deficiency (ID) and iron deficiency anaemia (IDA) among adolescent girls remains a public health concern for Bangladesh. The objective of the current analysis was to examine baseline data from an effectiveness trial with the aim to compare prevalence of anemia, ID and IDA with Bangladesh's National Micronutrients Status Survey 2011–12. Methods A community-based, double-blind, cluster randomized controlled trial is being conducted among n = 1260 Bangladeshi adolescent girls (10–17 years). Treatment groups include: 1) Fe-fortified lentils; 2) unfortified lentils and 3) usual intake (no intervention). Within the lentil groups, participants are being served 250 g cooked lentils with half a cup of cooked rice 5 days/week for 85 feeding days. All Fe-fortification and processing of lentils were carried out at the University of Saskatchewan. Anemia, ID and IDA were defined according to WHO (2011) cut-off values. Results At baseline, age of participants was 13.5 ± 2.0 years; BMI 18.2 ± 3.0 kg/m2 (or 38th percentile BMI-for-age); hemoglobin 12.4 ± 1.1 g/dL, serum ferritin 54.2 ± 36.3 ng/mL, sTfR 3.7 ± 2.6 µg/mL, and CRP 1.2 ± 3.9 mg/L. 26.6% girls were clinically anemic (non-pregnant-Hb <12 g/dl), 19.9% of those were mildly anemic (non-pregnant-Hb: 11–11.9 g/dl), 5.9% were moderately anemic (non-pregnant-Hb: 8.0–10.9 g/dl) anemic, and 0.8% were severely anemic (<8.0 g/dL). We found 9.2% of girls were ID (serum ferritin <15 µg/l). Conclusions One-fourth of rural Bangladeshi adolescent girls were anemic, and one-tenth were ID. This shows that rural anemia prevalence has increased ∼8.5% (26.6% vs 18.1%), ID has slightly increased (9.2% vs 10.0%) and IDA has increased (6.1% vs 1.8%) over the 7 years since the Bangladesh National Micronutrients Status Survey 2011–12. We can conclude from these baseline data that Bangladesh has made poor progress in reducing adolescent girls’ anemia with public policy efforts. Funding Sources Global Institute for Food Security; Nutrition International.

scholarly journals The Efficacy of Consuming Iron-Fortified Lentils on Body Iron (Fe) Status in Bangladeshi Adolescent Girls: A Sustainable, Food-Based Solution to Iron Deficiency

2021 ◽  
Vol 5 (Supplement_2) ◽  
pp. 700-700
Author(s):  
Fakir Yunus ◽  
Chowdhury Jalal ◽  
Anupom Das ◽  
Kaosar Afsana ◽  
Rajib Podder ◽  
...  
Keyword(s):  
Iron Deficiency ◽  
Adolescent Girls ◽  
Iron Status ◽  
Controlled Trial ◽  
Health Concern ◽  
Community Based ◽  
Double Blind ◽  
Sustainable Food ◽  
Funding Sources ◽  
Cluster Randomized

Abstract Objectives Iron deficiency (ID) and iron deficiency anaemia (IDA) remain a public health concern among women and girls globally, and have numerous impacts on health, nutrition and socioeconomic status. Our objective was to investigate the efficacy of consuming iron-fortified lentils on iron status among rural Bangladeshi adolescent girls. Methods In this community-based, double-blind, cluster-randomized controlled trial, girls (13.5 ± 2.0 years) were randomly assigned to three groups that received 1)cooked iron-fortified lentils (160 ppm Fe NaFeEDTA per kg of lentils); 2)cooked non-iron-fortified lentils; or 3)no lentils (usual intake group). We served 200 g of cooked lentils using a local daal recipe on five days/week, for 4 months. Iron status (sFer, sTfR, and Hgb) was assessed at baseline, 2 and 4 months. All analyses were adjusted for inflammation. Results There were no differences in baseline iron status among the three groups. sFer significantly increased by 21.9% (+5.7 μg/L, p &lt; 0.001; 95% CI: 1.7, 9.5 μg/L) from baseline to 4 months in the iron-fortified lentil group, compared to a decline in sFer observed in the non-iron fortified lentil (53.3 vs. 38.6 μg/L, p &lt; 0.01) and no lentil groups (53.6 vs. 39.5 μg/L, p &lt; 0.01). Examining overall changes in iron status over 4 months, we observed maintenance in the iron-fortified group from baseline, compared to a decline in the other groups. Conclusions We observed improvement in and maintenance of iron status in a population vulnerable to ID and IDA who consumed iron-fortified lentils for 4 months. Additionally, girls who consumed iron-fortified lentils had a 60% lower chance of developing clinical and subclinical ID (sFer &lt; 15, 15–30 μg/L), and a 70% lower chance of developing sub-clinical IDA (sFer 15–30 μg/L + Hgb &lt; 12 g/dL) compared to those who did not. Funding Sources Global Institute for Food Security.

A phase I randomized, double-blind, controlled trial of 2009 influenza A (H1N1) inactivated monovalent vaccines with different adjuvant systems

Vaccine ◽  
2011 ◽  
Vol 29 (48) ◽  
pp. 8974-8981 ◽  
Author(s):  
Alexander R. Precioso ◽  
João L. Miraglia ◽  
Lúcia Maria A. Campos ◽  
Alessandra C. Goulart ◽  
Maria do Carmo S.T. Timenetsky ◽  
...  
Keyword(s):  
Phase I ◽  
Influenza A ◽  
Controlled Trial ◽  
Double Blind ◽  
Influenza A H1n1

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

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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