Non-anemic Iron DeficiencyNCT05423249
Treatment of Non-Anemic Iron Deficiency in Pregnancy
A study testing Ferrous sulfate, Prenatal and Docusate Sodium in people with Non-anemic Iron Deficiency, run by Stony Brook University at 3 sites in United States.
Trial summary
The objective is to investigate the treatment of non-anemic iron deficiency (NAID) and the impact on development of anemia later in pregnancy. Anemia in the third trimester has been identified as a risk factor for maternal and fetal morbidity that might lead to mortality. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Non-anemic Iron Deficiency
- What is being tested?
- Ferrous sulfate, Prenatal and Docusate Sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- 12 Aug 2022to 15 Nov 2024
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- English speaking
- age 18-55
- less than 20 weeks gestational age
- low ferritin level (<30mcg/L) in the first trimester
- normal hemoglobin level (>11g/dL) in the first trimester
Who cannot join
- Women with anemia diagnosed in the first trimester (HgB ≤11 g/dL)
- Women with antepartum iron supplementation, except prenatal vitamin, within 3 months
- Women with iron overload or hypersensitivity
- Women with significant vaginal bleeding prior to enrollment
- Women with chronic illness: SLE, hemoglobinopathies, HIV, inflammatory bowel disease, active cancer, prior bariatric surgery
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University Associates in Obstetrics & Gynecology
Bohemia, New York, 11716
University Associates in Obstetrics & Gynecology
Commack, New York, 11725
University Associates in Obstetrics & Gynecology
East Setauket, New York, 11733
About this study
Official title: Treatment of Non-Anemic Iron Deficiency in Pregnancy: a Double-Blind Randomized Control Trial
The objective is to investigate the treatment of non-anemic iron deficiency (NAID) and the impact on development of anemia later in pregnancy. Anemia in the third trimester has been identified as a risk factor for maternal and fetal morbidity that might lead to mortality. Due to the high incidence of NAID in pregnancy, there is an opportunity for early screening and treatment to decrease progression to anemia. The primary aim of this study is to establish if treatment of NAID will result in higher third trimester hemoglobin values and decrease incidence of anemia at term.
Read the detailed description
All women who fit the inclusion criteria will be approached to be recruited for participation at Stony Brook University Hospital outpatient clinic at less than 20 weeks gestational age. Women who agree to participate in the study will be consented. The study team member will obtain consent from participants and randomize the patient into either the treatment or placebo group based on a 1:1 randomization scheme generated by randomization.com. The study team member will remain blinded, as randomization of subjects will be coordinated by departmental research coordinator, who will not have any interaction with subjects. The treatment group will receive oral ferrous sulfate 325mg (containing 65 mg of elemental iron) daily and a prenatal vitamin, and the placebo group will receive prenatal vitamin and a placebo pill. The prenatal vitamin, which contains iron, will be the same exact formula and will be given to all participants in both control and treatment groups. Only the treatment group will receive the extra iron supplement. The treatment group will also receive vitamin C 500mg daily to assist with iron absorption. Both groups will receive oral docusate sodium (Colace) 100mg twice daily as needed to decrease the risk of constipation.
The randomization will be blinded to the participant, along with the medical provider and study team. Since the Research Pharmacy is able to combine the iron and Vitamin C into one pill, and both groups will receive Colace and prenatal vitamin, the total pill count will not differ from the treatment group and placebo group.
Patients who agree to participate in the study will continue with routine prenatal care and testing, which includes a repeat complete blood count (CBC) in both the second and third trimester, at approximately 24-28 weeks and 34-36 weeks, as is standard of care. In the second and third trimester, a questionnaire will be given to the subject to assess fatigue scores, experience of side effects and severity of side effects. At that time, a study team member will also perform a pill count to assess for compliance.
At time of admission to the hospital for delivery, a repeat ferritin level will be drawn with routine lab work, including a CBC, with no additional risk of blood draw to the patient as this is part of standard of care. The ferritin test will be for research purposes for the study, but will not require an additional blood draw. Clinical anemia will be defined as a hemoglobin level less than or equal to 11 g/dL. While there is no normative data in the literature on ferritin levels in pregnancy, we will define a low ferritin level as <30 mcg/L based on both retrospective pregnancy data and standardized ferritin levels in the non pregnant patient population.
- Conditions
- Non-anemic Iron Deficiency
- Being tested
- Ferrous sulfate, Prenatal, Docusate Sodium, Ascorbic Acid 500Mg Tab, Placebo
- Medical subject headings
- Iron Deficiencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferrous sulfateDrug
Oral ferrous sulfate 325 mg once daily, containing 65 mg of elemental iron to treat non-anemic iron deficiency
PrenatalDrug
Oral prenatal vitamin once daily for both groups
Docusate SodiumDrug
Oral docusate sodium 100 mg twice daily as needed, to treat constipation secondary to oral iron supplementation
Ascorbic Acid 500Mg TabDrug
Oral ascorbic acid 500 mg daily, to improve absorption of oral iron
PlaceboDrug
Oral placebo pill once daily
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | The treatment group will receive oral ferrous sulfate 325mg (containing 65 mg of elemental iron) once daily, an oral prenatal vitamin once daily, oral ascorbic acid 500mg once daily, and oral docusate sodium 100mg twice daily as needed. Receives: Drug: Ferrous sulfate; Drug: Prenatal; Drug: Docusate Sodium; Drug: Ascorbic Acid 500Mg Tab |
| Placebo Group | Placebo comparator | The placebo group will receive a placebo bill, the same oral prenatal vitamin, and oral docusate sodium 100mg twice daily as needed. Receives: Drug: Prenatal; Drug: Docusate Sodium; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery admission hemoglobin
hemoglobin value <11 mg/dL
Measured: From date of randomization until to 42 weeks
Third trimester hemoglobin
Incidence of anemia, hemoglobin value <11 mg/dL, in the third trimester
Measured: 28 weeks to 36 weeks
Secondary outcomes (9)
Maternal anemia
Timing of diagnosis
Measured: Enrollment to 30 days postpartum
Incidence of preterm delivery
Preterm delivery rate
Measured: Enrollment to 30 days postpartum
Incidence of maternal hemorrhage
Postpartum hemorrhage rate
Measured: Enrollment to 30 days postpartum
Incidence of treatment of anemia
Need for IV iron or blood transfusion
Measured: Enrollment to 30 days postpartum
Incidence of infection
infection rate
Measured: Enrollment to 30 days postpartum
Maternal hospital stay
length of hospital stay
Measured: Enrollment to 30 days postpartum
Infant weight
Birth weight Birth weight, NICU admission, perinatal death
Measured: Time of birth to 30 days of life
Incidence of neonatal intensive care unit admission
Rate of NICU admission Birth weight, NICU admission, perinatal death
Measured: Time of birth to 30 days of life
Rate of poor perinatal outcome
Incidence of perinatal death Birth weight, NICU admission, perinatal death
Measured: Time of birth to 30 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start12 Aug 2022
- Primary completion1 Nov 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-anemic Iron DeficiencyStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Herrera, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423249
- Sponsor's protocol ID
- IRB2022-00121
- Status last verified
- Nov 2024
- First submitted
- 19 May 2022
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Non-Anemic Iron Deficiency in Pregnancy: a Double-Blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05423249
- Acronym / sponsor ID
- IRB2022-00121
- Conditions
- Non-anemic Iron Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 12 Aug 2022 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 21 Jun 2022 (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.
The objective is to investigate the treatment of non-anemic iron deficiency (NAID) and the impact on development of anemia later in pregnancy. Anemia in the third trimester has been identified as a risk factor for maternal and fetal morbidity that might lead to mortality. Due to the high incidence of NAID in pregnancy, there is an opportunity for early screening and treatment to decrease progression to anemia. The primary aim of this study is to establish if treatment of NAID will result in higher third trimester hemoglobin values and decrease incidence of anemia at term.
Detailed description
All women who fit the inclusion criteria will be approached to be recruited for participation at Stony Brook University Hospital outpatient clinic at less than 20 weeks gestational age. Women who agree to participate in the study will be consented. The study team member will obtain consent from participants and randomize the patient into either the treatment or placebo group based on a 1:1 randomization scheme generated by randomization.com. The study team member will remain blinded, as randomization of subjects will be coordinated by departmental research coordinator, who will not have any interaction with subjects. The treatment group will receive oral ferrous sulfate 325mg (containing 65 mg of elemental iron) daily and a prenatal vitamin, and the placebo group will receive prenatal vitamin and a placebo pill. The prenatal vitamin, which contains iron, will be the same exact formula and will be given to all participants in both control and treatment groups. Only the treatment group will receive the extra iron supplement. The treatment group will also receive vitamin C 500mg daily to assist with iron absorption. Both groups will receive oral docusate sodium (Colace) 100mg twice daily as needed to decrease the risk of constipation.
The randomization will be blinded to the participant, along with the medical provider and study team. Since the Research Pharmacy is able to combine the iron and Vitamin C into one pill, and both groups will receive Colace and prenatal vitamin, the total pill count will not differ from the treatment group and placebo group.
Patients who agree to participate in the study will continue with routine prenatal care and testing, which includes a repeat complete blood count (CBC) in both the second and third trimester, at approximately 24-28 weeks and 34-36 weeks, as is standard of care. In the second and third trimester, a questionnaire will be given to the subject to assess fatigue scores, experience of side effects and severity of side effects. At that time, a study team member will also perform a pill count to assess for compliance.
At time of admission to the hospital for delivery, a repeat ferritin level will be drawn with routine lab work, including a CBC, with no additional risk of blood draw to the patient as this is part of standard of care. The ferritin test will be for research purposes for the study, but will not require an additional blood draw. Clinical anemia will be defined as a hemoglobin level less than or equal to 11 g/dL. While there is no normative data in the literature on ferritin levels in pregnancy, we will define a low ferritin level as <30 mcg/L based on both retrospective pregnancy data and standardized ferritin levels in the non pregnant patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Ferrous sulfate, Drug: Prenatal, Drug: Docusate Sodium, Drug: Ascorbic Acid 500Mg TabThe treatment group will receive oral ferrous sulfate 325mg (containing 65 mg of elemental iron) once daily, an oral prenatal vitamin once daily, oral ascorbic acid 500mg once daily, and oral docusate sodium 100mg twice daily as needed. |
| Placebo Group | Placebo comparator | Drug: Prenatal, Drug: Docusate Sodium, Drug: PlaceboThe placebo group will receive a placebo bill, the same oral prenatal vitamin, and oral docusate sodium 100mg twice daily as needed. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- English speaking
- age 18-55
- less than 20 weeks gestational age
- low ferritin level (<30mcg/L) in the first trimester
- normal hemoglobin level (>11g/dL) in the first trimester
Key exclusion criteria (5 listed)
- Women with anemia diagnosed in the first trimester (HgB ≤11 g/dL)
- Women with antepartum iron supplementation, except prenatal vitamin, within 3 months
- Women with iron overload or hypersensitivity
- Women with significant vaginal bleeding prior to enrollment
- Women with chronic illness: SLE, hemoglobinopathies, HIV, inflammatory bowel disease, active cancer, prior bariatric surgery
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 sulfateOral ferrous sulfate 325 mg once daily, containing 65 mg of elemental iron to treat non-anemic iron deficiency | Drug | Treatment Group |
| PrenatalOral prenatal vitamin once daily for both groups | Drug | Placebo Group, Treatment Group |
| Docusate SodiumOral docusate sodium 100 mg twice daily as needed, to treat constipation secondary to oral iron supplementation | Drug | Placebo Group, Treatment Group |
| Ascorbic Acid 500Mg TabOral ascorbic acid 500 mg daily, to improve absorption of oral iron | Drug | Treatment Group |
| PlaceboOral placebo pill once daily | Drug | Placebo Group |
Primary outcome
Delivery admission hemoglobin
Time frame: From date of randomization until to 42 weeks
hemoglobin value <11 mg/dL
Third trimester hemoglobin
Time frame: 28 weeks to 36 weeks
Incidence of anemia, hemoglobin value <11 mg/dL, in the third trimester
9 secondary outcomes
Maternal anemia
Time frame: Enrollment to 30 days postpartum
Incidence of preterm delivery
Time frame: Enrollment to 30 days postpartum
Incidence of maternal hemorrhage
Time frame: Enrollment to 30 days postpartum
Incidence of treatment of anemia
Time frame: Enrollment to 30 days postpartum
Incidence of infection
Time frame: Enrollment to 30 days postpartum
Maternal hospital stay
Time frame: Enrollment to 30 days postpartum
Infant weight
Time frame: Time of birth to 30 days of life
Incidence of neonatal intensive care unit admission
Time frame: Time of birth to 30 days of life
Rate of poor perinatal outcome
Time frame: Time of birth to 30 days of life
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 29 Nov 2024.
- Individual participant dataSharing planned: No
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Active, not recruiting
The Immediate and Long-term Effects of a Novel Marine-based Iron Supplement in Adult Females
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ferrous sulfate, Prenatal and Docusate Sodium in people with Non-anemic Iron Deficiency, run by Stony Brook University at 3 sites 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 5 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 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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?
Delivery admission hemoglobin (time frame: From date of randomization until to 42 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2024.