Iron Supplements for Iron Deficiency in Pregnancy
(EASE-Iron Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of British Columbia
Must not be taking: Proton pump inhibitors, antibiotics
Disqualifiers: Sickle cell, Celiac, Smoking, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This two-arm, double-blind randomized clinical trial will recruit 172 generally healthy, low-risk pregnant individuals aged 19-42 years living in Vancouver, Canada. Participants will be randomized to receive one of two forms of iron (ferrous fumarate or ferrous bisglycinate) in addition to a prenatal multivitamin (without iron) daily during their pregnancy until delivery, with optional continuation until \~4 weeks postpartum for breastmilk sample collection. Blood samples will be taken at baseline (13-25 weeks gestation) and follow-up (35-37 weeks gestation) to assess how different forms of iron impact body iron stores. Stool samples will be obtained within 1 week of both baseline and follow-up visits to assess changes in gut microbiome composition. This research will inform more specific guidelines for optimal iron supplementation practices for the prevention and treatment of iron deficiency for both mother and baby.
Will I have to stop taking my current medications?
The trial requires that you do not use medications known to interfere with iron metabolism or gut health, such as proton pump inhibitors, anti-inflammatory agents, non-steroidal anti-inflammatory drugs, and antibiotics.
What data supports the effectiveness of the drug Ferrous bisglycinate for treating iron deficiency in pregnancy?
Research shows that Ferrous bisglycinate is effective in increasing iron levels in pregnant women with iron deficiency, with studies indicating it is as effective as other iron supplements like ferrous sulfate and ferrous fumarate, but with potentially fewer side effects.
12345Is it safe to take iron supplements like ferrous bisglycinate during pregnancy?
Research shows that ferrous bisglycinate is generally safe for humans, with fewer stomach-related side effects compared to other iron supplements. Studies in pregnant women and animals indicate it is well-tolerated and effective in increasing iron levels without significant adverse effects.
12467How does the drug Ferrous bisglycinate differ from other treatments for iron deficiency in pregnancy?
Ferrous bisglycinate is unique because it is more bioavailable (easier for the body to absorb) and causes fewer stomach-related side effects compared to traditional iron salts like ferrous fumarate. This makes it a more effective and tolerable option for pregnant women with iron deficiency.
12389Eligibility Criteria
This trial is for healthy pregnant individuals aged 19-42 in Vancouver, expecting one baby and planning to deliver at BC Women's Hospital. They should be 13-25 weeks into their pregnancy and able to visit the University of British Columbia. Exclusions include a BMI ≥30, smoking recently, certain pre-existing conditions affecting iron levels, or use of specific medications.Inclusion Criteria
You are in your second trimester of pregnancy, between 13 and 25 weeks.
I am pregnant, between 19 and 42 years old, and expecting one baby.
I plan to give birth at BC Women's Hospital.
+2 more
Exclusion Criteria
You have a history of neural tube defects or have had a previous pregnancy with a neural tube defect.
I have a health condition that affects my body's iron levels.
I am currently receiving blood transfusions.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person)
Baseline
Baseline visit includes informed consent, randomization, provision of study supplements, and collection of baseline data
1 day
1 visit (in-person)
Treatment
Participants receive daily iron and prenatal multivitamin supplements from baseline to delivery, with monthly follow-up surveys
12 weeks
Monthly virtual follow-ups
Follow-up
Follow-up visit includes collection of remaining supplements, weight measurement, blood draw, and stool collection
2 weeks
1 visit (in-person)
Optional Continuation
Participants who plan to breastfeed may continue supplementation and provide breastmilk samples postpartum
4 weeks postpartum
Participant Groups
The study tests two types of iron supplements: Ferrous fumarate and Ferrous bisglycinate taken with prenatal vitamins during pregnancy until delivery. The goal is to compare how each supplement affects body iron stores and gut bacteria presence by analyzing blood samples and rectal swabs from start till around week 37.
2Treatment groups
Experimental Treatment
Active Control
Group I: Ferrous bisglycinateExperimental Treatment1 Intervention
24 mg elemental iron/day
Group II: Ferrous fumarateActive Control1 Intervention
24 mg elemental iron/day
Ferrous bisglycinate is already approved in Canada, European Union, United States for the following indications:
🇨🇦 Approved in Canada as Ferrous bisglycinate for:
- Prevention and treatment of iron deficiency in pregnancy
🇪🇺 Approved in European Union as Ferrous bisglycinate for:
- Prevention and treatment of iron deficiency in pregnancy
🇺🇸 Approved in United States as Ferrous bisglycinate for:
- Prevention and treatment of iron deficiency in pregnancy
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of British Columbia, Food, Nutrition and Health BuildingVancouver, Canada
BC Women's HospitalVancouver, Canada
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Who Is Running the Clinical Trial?
University of British ColumbiaLead Sponsor
References
Efficacy and Safety of Ferrous Bisglycinate and Folinic Acid in the Control of Iron Deficiency in Pregnant Women: A Randomized, Controlled Trial. [2023]Iron deficiency in pregnancy is a major public health problem that causes maternal complications. The objective of this randomized, controlled trial was to examine the bioavailability, efficacy, and safety of oral ferrous bisglycinate plus folinic acid supplementation in pregnant women with iron deficiency. Subjects (12−16 weeks of gestation, n = 120) were randomly allocated to receive oral iron as ferrous bisglycinate (equiv. iron 24 mg) in supplement form with folinic acid and multivitamins (test group, n = 60) or as ferrous fumarate (equiv. iron 66 mg iron, control group, n = 60) after breakfast daily. Iron absorption was assessed by measuring fasted serum iron levels at 1 and 2 h immediately after supplementation. Hematological biomarkers and iron status were assessed before intervention, and at 3 and 6 months. Side effects were monitored throughout the intervention. A significant increase in serum iron was seen in both groups (p
The effects of oral ferrous bisglycinate supplementation on hemoglobin and ferritin concentrations in adults and children: a systematic review and meta-analysis of randomized controlled trials. [2023]Iron deficiency and anemia have serious consequences, especially for children and pregnant women. Iron salts are commonly provided as oral supplements to prevent and treat iron deficiency, despite poor bioavailability and frequently reported adverse side effects. Ferrous bisglycinate is a novel amino acid iron chelate that is thought to be more bioavailable and associated with fewer gastrointestinal (GI) adverse events as compared with iron salts.
Ferrous bisglycinate 25 mg iron is as effective as ferrous sulfate 50 mg iron in the prophylaxis of iron deficiency and anemia during pregnancy in a randomized trial. [2019]To compare the effects of oral ferrous bisglycinate 25 mg iron/day vs. ferrous sulfate 50 mg iron/day in the prevention of iron deficiency (ID) and iron deficiency anemia (IDA) in pregnant women.
Amino acid chelated iron versus an iron salt in the treatment of iron deficiency anemia with pregnancy: A randomized controlled study. [2018]The aim of this study was to compare the efficacy and tolerability of iron amino acid chelate (IAAC) and ferrous fumarate (FF) in treatment of iron deficiency anemia (IDA) with pregnancy.
Efficacy and tolerability of oral bovine lactoferrin compared to ferrous sulfate in pregnant women with iron deficiency anemia: a prospective controlled randomized study. [2014]To compare the effects of bovine lactoferrin with ferrous sulfate on iron nutritional status and to evaluate their tolerability in 100 pregnant women with iron deficiency anemia.
Safety evaluation of ferrous bisglycinate chelate. [2019]Ferrous bisglycinate chelate (Ferrochel) is a highly stable chelate that can be added to most foods. Data from human and animal studies indicate that the ferrous iron is readily bioavailable with fewer side-effects than the more commonly used iron salts. The acute oral LD50 for male and female Sprague-Dawley (S-D) rats is 2800 mg/kg body weight (560 mg/kg body weight iron [confidence limit (CL) 399-786] as the active ingredient). Male and female CD (Sprague Dawley-derived) rats were fed ferrous bisglycinate as a dietary admixture at doses of 0, 100, 250 and 500 mg/kg body weight/day. There were no biologically or statistically significant dose-related differences between the control and treated animals with respect to body weight gain, food consumption, food efficiency, behavioural effects, clinical chemistries, haematology, absolute and relative organ weights, or gross and microscopic findings. Hepatic non-heme iron concentrations were elevated, indicating that the ferrous iron had been absorbed. The no-observed-adverse-effect level (NOAEL) was 500 mg/kg body weight/day, the highest dose tested.
Iron amino acid chelates. [2013]Iron amino acid chelates, such as iron glycinate chelates, have been developed to be used as food fortificants and therapeutic agents in the prevention and treatment of iron deficiency anemia. Ferrous bis-glycine chelate (FeBC), ferric tris-glycine chelate, ferric glycinate, and ferrous bis-glycinate hydrochloride are available commercially. FeBC is the most studied and used form. Iron absorption from FeBC is affected by enhancers and inhibitors of iron absorption, but to a lesser extent than ferrous sulfate. Its absorption is regulated by iron stores. FeBC is better absorbed from milk, wheat, whole maize flour, and precooked corn flour than is ferrous sulfate. Supplementation trials have demonstrated that FeBC is efficacious in treating iron deficiency anemia. Consumption of FeBC-fortified liquid milk, dairy products, wheat rolls, and multi-nutrient beverages is associated with an improvement of iron status. The main limitations to the widespread use of FeBC in national fortification programs are the cost and the potential for promoting organoleptic changes in some food matrices. Additional research is required to establish the bioavailability of FeBC in different food matrices. Other amino acid chelates should also be evaluated. Finally there is an urgent need for more rigorous efficacy trials designed to define the relative merits of amino acid chelates when compared with bioavailable iron salts such as ferrous sulfate and ferrous fumarate and to determine appropriate fortification levels
Relative effectiveness of iron bis-glycinate chelate (Ferrochel) and ferrous sulfate in the control of iron deficiency in pregnant women. [2022]The relative effectiveness of daily supplementation of iron deficiency during pregnancy using 15 mg/day of iron from iron-bis-glycinate chelate (71 pregnant women), or 40 mg iron from ferrous sulfate (74 pregnant women) was evaluated by measuring hemoglobin, transferrin saturation and serum ferritin, at the beginning of the study (
Efficacy of ferrous bis-glycinate versus ferrous glycine sulfate in the treatment of iron deficiency anemia with pregnancy: a randomized double-blind clinical trial. [2020]Objective: The aim of this study is to compare the efficacy and tolerability of oral ferrous bis-glycinate versus ferrous glycine sulfate in the treatment of iron deficiency anemia (IDA) with pregnancy.Methods: A randomized double-blind clinical trial (NCT02590224) conducted at a tertiary University Hospital in the period between 1 January 2016 and 31 July 2017 included pregnant women at 14-18 weeks of gestation with mild to moderate IDA. Patients were randomized into two groups: (Group I) received oral ferrous bis-glycinate tablets once daily for eight consecutive weeks and (Group II) received oral ferrous glycine sulfate capsules in the same dose and duration. The primary outcome of the study was the rate of increase of hemoglobin (HB) level after 8 weeks of iron treatment.Results: The study included 187 women in the final analysis. The mean increase in HB level after 8 weeks of treatment in ferrous bis-glycinate group was 2.48 ± 0.12 g/dL versus 1.32 ± 0.18 g/dL in ferrous glycine sulfate group (p ≤ .0001). The percentage of women with HB level more than 11 g/dL after 8 weeks of treatment was 89.2% in ferrous bis-glycinate group versus 71.3% in ferrous glycine sulfate group (p < .0001). The rate of adverse effects was significantly higher in ferrous glycine sulfate group (p = .001).Conclusions: Pregnant women with second trimester IDA could be supplied with ferrous bis-glycinate which is more efficient in increasing HB level. Moreover, it has tolerable adverse effects and high compliance than ferrous glycine sulfate.