Iron Deficiency AnemiaNCT03562143
Daily vs Alternate Day Iron Supplementation for Pregnant Women With Iron Deficiency Anemia
A study testing Ferrous Sulfate in people with Iron Deficiency Anemia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Iron deficiency is thought to be the most common nutrient deficiency among pregnant women and the most common cause of anemia in pregnancy. The consequences of iron deficiency anemia are serious and can include diminished intellectual and productive capacity and possibly increased susceptibility to infection in… Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- Ferrous Sulfate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2018to 20 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant patients with iron deficiency anemia, defined as Hb less than 11.0 or hematocrit less than 33% with ferritin 25 ug/L
- Age 18-64 years old.
- Gestational age between 12 0/7 weeks and 34 0/7 weeks.
- No other known causes of anemia (Folate or vit b12 deficiency anemia, sideroblastic anemia, thalassemia, sickle cell anemia, aplastic anemia, hemolytic anemia, anemia of chronic disease). Anemic patients with a low ferritin level and a mean corpuscular volume (MCV) >95 will have folate and vitamin B12 measured since some patients might have combined causes of anemia and might not respond as expected to iron supplementation only.
- Patients will also be required to have a normal HB electrophoresis; this is a routine test obtained on all prenatal patients.
Who cannot join
- Patients currently receiving iron supplementation
- Malabsorptive and restrictive bariatric surgery
- Inflammatory bowel disease
- Irritable bowel syndrome
- Celiac disease/atrophic gastritis/Helicobacter pylori
- Active infection (ferritin can be falsely elevated since apoferritin is an acute-phase protein like CRP and increases both during infections and inflammatory reactions eg postoperatively).
- Patients with contraindications to iron supplementation such as iron overload or hypersensitivity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Daily vs Alternate Day Iron Supplementation for Pregnant Women With Iron Deficiency Anemia: A Randomized Controlled
Iron deficiency is thought to be the most common nutrient deficiency among pregnant women and the most common cause of anemia in pregnancy. The consequences of iron deficiency anemia are serious and can include diminished intellectual and productive capacity and possibly increased susceptibility to infection in mothers and infants, low birthweight, and premature births, hence the importance of appropriate treatment during pregnancy.
Most guidelines recommend an increase in iron consumption by about 15-30 mg/day, an amount readily met by most prenatal vitamin formulations. This is adequate supplementation for non-anemic and non-iron-deficient women. However, women with iron deficiency anemia should receive an additional 30-20 mg/day until the anemia is corrected.
Read more
It is not clear whether intermittent administration of oral iron is equivalent to once daily to rise the hemoglobin levels in pregnant women with iron deficiency anemia. Alternate day treatment with supplemental iron has been suggested as a way to improve its absorption because daily doses may suppress the mucosal uptake of iron even in the presence of iron deficiency until the intestinal mucosa completes its turnover.
Another possible factor associated with the frequency of iron dosing is related to hepcidin, the central regulatory molecule in the metabolism of iron in mammals. The synthesis of hepcidin is controlled by 3 kinds of signals: inflammation; the need for increased erythropoiesis, and an iron status signal based on plasma iron levels and iron stores. If plasma iron levels or iron stores are increased, the resulting signal increases hepcidin levels, thereby blocking iron absorption and its release from stores (liver, macrophages) and preventing iron overload.This hepcidin effect, suppressing iron absorption, could last as long as 48h.
In this study, the researchers aim to determine if alternate day dosing of iron in pregnant women with iron deficiency anemia results in improved levels of hemoglobin or hematocrit and ferritin.
Hepcidin levels will be compared between patients on daily iron supplementation versus alternate day supplementation.
The researchers will also evaluate if alternate day dosing of iron supplementation results in a better side effect profile, and with better patient compliance.
- Conditions
- Iron Deficiency Anemia
- Being tested
- Ferrous Sulfate
- Keywords
- Iron, Deficiency, Anemia, Supplementation, Pregnancy
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous SulfateDietary supplement
Also called Alternate-day iron supplementation
Patients will take iron supplementation given as 2 tabs of 325 mg ferrous sulfate (equivalent to 130 mg of elemental iron) on alternate day for 6 weeks.
Ferrous SulfateDietary supplement
Also called Daily iron supplementation
Patients will take iron supplementation given as 1 tab of 325 mg ferrous sulfate (equivalent to 65 mg of elemental iron) daily for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Alternate-day iron supplementation | Experimental | Patients taking iron supplementation given as 2 tabs of 325 mg ferrous sulfate (equivalent to 130 mg of elemental iron) for 6 weeks. Receives: Dietary Supplement: Ferrous Sulfate |
| Daily iron supplementation | Active comparator | Patients taking iron supplementation given as 1 tab of 325 mg ferrous sulfate (equivalent to 65 mg of elemental iron) for 6 weeks. Receives: Dietary Supplement: Ferrous Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin Level
The change in the level of hemoglobin in pregnant patients with iron deficiency anemia after 6 weeks of treatment with either daily or alternate-day iron supplementation.
Measured: baseline and 6 weeks
Secondary outcomes (3)
Change in Ferritin Level
Change in the level of ferritin in pregnant patients with iron deficiency anemia after 6 weeks of treatment with either daily or alternate-day iron supplementation.
Measured: baseline and 6 weeks
Change in Fasting Hepcidin Level
At the end of the 6 weeks of treatment, hepcidin levels will be obtained on day 43 of the study. The 6-week hepcidin level will be compared to the starting hepcidin which will be drawn prior to initiating iron supplementation.
Measured: Baseline and Day 43 post treatment
Side effects from Iron Supplementation Questionnaire
Patients will be asked to fill a questionnaire after 6 weeks to assess for adverse symptoms associated with consumption of iron including constipation, nausea, vomiting, diarrhea, abdominal pain, and headache. Each of these items is scaled from 0 (not al all) to 10 (very much), with total scale from 0-60, with higher score indicating more severe symptoms.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start31 Aug 2018
- Primary completion20 Feb 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency AnemiaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients that agree to participate will be randomized to receive either 1 tablet of 325mg ferrous sulfate (65 mg of elemental iron) on consecutive days for 6 weeks or 2 tablets together (130 mg of elemental iron ) every other day for 6 weeks. Both groups will be receiving the same total amount of iron over the study period (2730 mg of elemental iron over 6 weeks).
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melissa T Chu Lam, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03562143
- Sponsor's protocol ID
- GCO 18-1781
- Status last verified
- Mar 2020
- First submitted
- 7 Jun 2018
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sloan NL, Jordan E, Winikoff B. Effects of iron supplementation on maternal hematologic status in pregnancy. Am J Public Health. 2002 Feb;92(2):288-93. doi: 10.2105/ajph.92.2.288.
PubMed 11818308Alleyne M, Horne MK, Miller JL. Individualized treatment for iron-deficiency anemia in adults. Am J Med. 2008 Nov;121(11):943-8. doi: 10.1016/j.amjmed.2008.07.012.
PubMed 18954837Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015 Feb 20;10(2):e0117383. doi: 10.1371/journal.pone.0117383. eCollection 2015.
PubMed 25700159Short MW, Domagalski JE. Iron deficiency anemia: evaluation and management. Am Fam Physician. 2013 Jan 15;87(2):98-104.
PubMed 23317073Moretti D, Goede JS, Zeder C, Jiskra M, Chatzinakou V, Tjalsma H, Melse-Boonstra A, Brittenham G, Swinkels DW, Zimmermann MB. Oral iron supplements increase hepcidin and decrease iron absorption from daily or twice-daily doses in iron-depleted young women. Blood. 2015 Oct 22;126(17):1981-9. doi: 10.1182/blood-2015-05-642223. Epub 2015 Aug 19.
PubMed 26289639Auerbach M, Adamson JW. How we diagnose and treat iron deficiency anemia. Am J Hematol. 2016 Jan;91(1):31-8. doi: 10.1002/ajh.24201. Epub 2015 Nov 17.
PubMed 26408108Allen LH. Anemia and iron deficiency: effects on pregnancy outcome. Am J Clin Nutr. 2000 May;71(5 Suppl):1280S-4S. doi: 10.1093/ajcn/71.5.1280s.
PubMed 10799402Breymann C. Iron Deficiency Anemia in Pregnancy. Semin Hematol. 2015 Oct;52(4):339-47. doi: 10.1053/j.seminhematol.2015.07.003. Epub 2015 Jul 10.
PubMed 26404445
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily vs Alternate Day Iron Supplementation for Pregnant Women With Iron Deficiency Anemia: A Randomized Controlled
- ClinicalTrials.gov ID
- NCT03562143
- Acronym / sponsor ID
- GCO 18-1781
- Conditions
- Iron Deficiency Anemia
- Keywords
- Iron, Deficiency, Anemia, Supplementation, Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Iron deficiency is thought to be the most common nutrient deficiency among pregnant women and the most common cause of anemia in pregnancy. The consequences of iron deficiency anemia are serious and can include diminished intellectual and productive capacity and possibly increased susceptibility to infection in mothers and infants, low birthweight, and premature births, hence the importance of appropriate treatment during pregnancy.
Most guidelines recommend an increase in iron consumption by about 15-30 mg/day, an amount readily met by most prenatal vitamin formulations. This is adequate supplementation for non-anemic and non-iron-deficient women. However, women with iron deficiency anemia should receive an additional 30-20 mg/day until the anemia is corrected.
It is not clear whether intermittent administration of oral iron is equivalent to once daily to rise the hemoglobin levels in pregnant women with iron deficiency anemia. Alternate day treatment with supplemental iron has been suggested as a way to improve its absorption because daily doses may suppress the mucosal uptake of iron even in the presence of iron deficiency until the intestinal mucosa completes its turnover.
Another possible factor associated with the frequency of iron dosing is related to hepcidin, the central regulatory molecule in the metabolism of iron in mammals. The synthesis of hepcidin is controlled by 3 kinds of signals: inflammation; the need for increased erythropoiesis, and an iron status signal based on plasma iron levels and iron stores. If plasma iron levels or iron stores are increased, the resulting signal increases hepcidin levels, thereby blocking iron absorption and its release from stores (liver, macrophages) and preventing iron overload.This hepcidin effect, suppressing iron absorption, could last as long as 48h.
In this study, the researchers aim to determine if alternate day dosing of iron in pregnant women with iron deficiency anemia results in improved levels of hemoglobin or hematocrit and ferritin.
Hepcidin levels will be compared between patients on daily iron supplementation versus alternate day supplementation.
The researchers will also evaluate if alternate day dosing of iron supplementation results in a better side effect profile, and with better patient compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients that agree to participate will be randomized to receive either 1 tablet of 325mg ferrous sulfate (65 mg of elemental iron) on consecutive days for 6 weeks or 2 tablets together (130 mg of elemental iron ) every other day for 6 weeks. Both groups will be receiving the same total amount of iron over the study period (2730 mg of elemental iron over 6 weeks).
| Arm | Type | Receives |
|---|---|---|
| Alternate-day iron supplementation | Experimental | Dietary Supplement: Ferrous SulfatePatients taking iron supplementation given as 2 tabs of 325 mg ferrous sulfate (equivalent to 130 mg of elemental iron) for 6 weeks. |
| Daily iron supplementation | Active comparator | Dietary Supplement: Ferrous SulfatePatients taking iron supplementation given as 1 tab of 325 mg ferrous sulfate (equivalent to 65 mg of elemental iron) for 6 weeks. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Pregnant patients with iron deficiency anemia, defined as Hb less than 11.0 or hematocrit less than 33% with ferritin 25 ug/L
- Age 18-64 years old.
- Gestational age between 12 0/7 weeks and 34 0/7 weeks.
- No other known causes of anemia (Folate or vit b12 deficiency anemia, sideroblastic anemia, thalassemia, sickle cell anemia, aplastic anemia, hemolytic anemia, anemia of chronic disease). Anemic patients with a low ferritin level and a mean corpuscular volume (MCV) >95 will have folate and vitamin B12 measured since some patients might have combined causes of anemia and might not respond as expected to iron supplementation only.
- Patients will also be required to have a normal HB electrophoresis; this is a routine test obtained on all prenatal patients.
Key exclusion criteria (7 listed)
- Patients currently receiving iron supplementation
- Malabsorptive and restrictive bariatric surgery
- Inflammatory bowel disease
- Irritable bowel syndrome
- Celiac disease/atrophic gastritis/Helicobacter pylori
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferrous SulfateAlso: Alternate-day iron supplementationPatients will take iron supplementation given as 2 tabs of 325 mg ferrous sulfate (equivalent to 130 mg of elemental iron) on alternate day for 6 weeks. | Dietary supplement | Alternate-day iron supplementation |
| Ferrous SulfateAlso: Daily iron supplementationPatients will take iron supplementation given as 1 tab of 325 mg ferrous sulfate (equivalent to 65 mg of elemental iron) daily for 6 weeks. | Dietary supplement | Daily iron supplementation |
Primary outcome
Change in Hemoglobin Level
Time frame: baseline and 6 weeks
The change in the level of hemoglobin in pregnant patients with iron deficiency anemia after 6 weeks of treatment with either daily or alternate-day iron supplementation.
3 secondary outcomes
Change in Ferritin Level
Time frame: baseline and 6 weeks
Change in Fasting Hepcidin Level
Time frame: Baseline and Day 43 post treatment
Side effects from Iron Supplementation Questionnaire
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Background: PubMed 11818308Sloan NL, Jordan E, Winikoff B. Effects of iron supplementation on maternal hematologic status in pregnancy. Am J Public Health. 2002 Feb;92(2):288-93. doi: 10.2105/ajph.92.2.288.
- Background: PubMed 18954837Alleyne M, Horne MK, Miller JL. Individualized treatment for iron-deficiency anemia in adults. Am J Med. 2008 Nov;121(11):943-8. doi: 10.1016/j.amjmed.2008.07.012.
- Background: PubMed 25700159Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015 Feb 20;10(2):e0117383. doi: 10.1371/journal.pone.0117383. eCollection 2015.
- Background: PubMed 23317073Short MW, Domagalski JE. Iron deficiency anemia: evaluation and management. Am Fam Physician. 2013 Jan 15;87(2):98-104.
- Background: PubMed 26289639Moretti D, Goede JS, Zeder C, Jiskra M, Chatzinakou V, Tjalsma H, Melse-Boonstra A, Brittenham G, Swinkels DW, Zimmermann MB. Oral iron supplements increase hepcidin and decrease iron absorption from daily or twice-daily doses in iron-depleted young women. Blood. 2015 Oct 22;126(17):1981-9. doi: 10.1182/blood-2015-05-642223. Epub 2015 Aug 19.
- Background: PubMed 26408108Auerbach M, Adamson JW. How we diagnose and treat iron deficiency anemia. Am J Hematol. 2016 Jan;91(1):31-8. doi: 10.1002/ajh.24201. Epub 2015 Nov 17.
- Background: PubMed 10799402Allen LH. Anemia and iron deficiency: effects on pregnancy outcome. Am J Clin Nutr. 2000 May;71(5 Suppl):1280S-4S. doi: 10.1093/ajcn/71.5.1280s.
- Background: PubMed 26404445Breymann C. Iron Deficiency Anemia in Pregnancy. Semin Hematol. 2015 Oct;52(4):339-47. doi: 10.1053/j.seminhematol.2015.07.003. Epub 2015 Jul 10.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa T Chu Lam, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous Sulfate in people with Iron Deficiency Anemia, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Hemoglobin Level (time frame: baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03562143, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.