Anemia of PregnancyLITSNPFNCT06669052
Liposomal Iron 30 mg Supplement in Non-anemic Pregnant Females
An observational study of Anemia of Pregnancy and Iron Deficiency Anemia, run by Orchidia pharmaceutical Industries.
Trial summary
Protocol Summary: Liposomal Iron Supplementation in Non-anemic Pregnant Females This observational study aims to evaluate the efficacy and safety of daily liposomal iron supplementation (30 mg) in non-anemic pregnant women during their second trimester of pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anemia of Pregnancy, Iron Deficiency Anemia
- What is being tested?
- 30 mg liposomal iron, capsules
- Type of treatment
- Pill or oral medicine
- How many people
- 714 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to May 2025
- How long will I take part?
- 90 Days
- Phase
- Observational
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This study will include non-anemic pregnant females > 18 years old taking liposomal iron in non-anemic pregnant females as an iron supplement during 14-16 weeks of pregnancy. The study will be conducted at approximately 100 investigative sites in Egypt. Recruitment will stop when approximately 714 subjects are enrolled.
Who may be able to join
- Pregnant females; gestational age from 14 to 16 weeks Age 18-45 years
- Low-risk pregnancy is defined as a pregnancy in which there is no high risk of problems or unfavorable outcomes, and the expectant mother and fetus are typically healthy
- Non-anemic women at the time of recruitment (hemoglobin level not less than 10.5. Hemoglobin measured within 2 or 3 weeks of recruitment
- Singleton pregnancy
- Agree to participate in the study including data collection from medical records and participation in related questionnaires.
Who cannot join
- Inadequate medical records
- Pregnant women living in areas away from the recruitment center
- Had any chronic health problem.
- Women with any form of hereditary anemia including sickle cell anemia, thalassemia, and Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- History of antepartum bleeding
- Refuse to sign the informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Liposomal Iron 30 mg Supplement in Non-anemic Pregnant Females an Observational Study
Protocol Summary: Liposomal Iron Supplementation in Non-anemic Pregnant Females This observational study aims to evaluate the efficacy and safety of daily liposomal iron supplementation (30 mg) in non-anemic pregnant women during their second trimester of pregnancy. The study will focus on pregnant females aged 18-45 years with low-risk, singleton pregnancies who are non-anemic (hemoglobin ≥10.5) at 14-16 weeks gestation.
Primary Research Question:
Read more
Does daily supplementation with 30 mg liposomal iron effectively maintain maternal hemoglobin levels over 90 days? Measured by: The difference in maternal hemoglobin levels between baseline and after 90 days of treatment in women recruited at 14-16 weeks gestation.
Secondary Research Questions:
What are the effects of liposomal iron supplementation on serum ferritin levels? Measured by: Changes in serum ferritin levels between baseline and after 90 days of treatment.
What is the safety profile of liposomal iron supplementation during pregnancy? Measured by: Maternal gastrointestinal side effects monitored at each prenatal visit (day 30, 60, and 90).
What is the compliance rate with liposomal iron supplementation? Measured by: Participant-reported compliance assessed at each prenatal visit (day 30, 60, and 90).
Participants will:
Receive daily liposomal iron supplementation (30 mg) for 90 days. Attend regular prenatal visits for monitoring at days 30, 60, and 90. Complete questionnaires about compliance and any adverse effects at each visit. Undergo blood tests to measure hemoglobin and serum ferritin levels at baseline and day 90.
This multi-center study will involve 714 participants across 100 sites, with recruitment beginning in November 2024 and study completion expected by July 2025. The study's findings will contribute to understanding the role of liposomal iron supplementation in preventing iron deficiency during pregnancy and its potential advantages over traditional iron supplements in terms of tolerability and compliance.
Read the detailed description
This observational, prospective study aims to evaluate the safety and efficacy of Liposomal Iron 30 mg supplement in non-anemic pregnant women during the second trimester (gestational weeks 14 to 16). Conducted at approximately 100investigative sites across Egypt, the study targets the enrollment of 714 participants.
The primary objective is to assess the impact of daily supplementation with liposomal iron over a 90-day period on maternal health. The study will monitor participants through routine prenatal visits, where data on adverse effects will be collected alongside routine hemoglobin and serum ferritin measurements.
The study will utilize a Data and Safety Monitoring Board (DSMB) to ensure oversight of participant safety and the integrity of study data. The DSMB will regularly review safety information and study progress, providing recommendations to the sponsor regarding the continuation or termination of the trial if necessary.
Statistical analyses will be performed using methods appropriate for the data collected, ensuring that the results will robustly assess the safety and efficacy of the liposomal iron supplement.
This study is designed to provide critical insights into iron supplementation for pregnant women, addressing a significant public health issue by exploring a formulation that may enhance compliance and reduce gastrointestinal side effects associated with traditional iron supplements.
- Conditions
- Anemia of Pregnancy, Iron Deficiency Anemia
- Being tested
- 30 mg liposomal iron, capsules
- Keywords
- 30 mg liposomal irom, non-anemic pregnant females, observational study, hemoglobin level, Second trimester
- Medical subject headings
- Anemia, Iron-Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 mg liposomal iron, capsulesDietary supplement
a dietary supplement capsule, of mainly 30 mg liposomal iron, and Vitamin C 70mg, vitamin D3 400IU, vitamin B6 1.75 mcg, Folate 1000 mcg, b=vitamin B12 10 mcg. all in capsulated in 1 Hard gelatin capsule
| Study group | Role | What they receive |
|---|---|---|
| 1 arm group, pregnant non-anemic females, second trimester. | Liposomal iron, capsules, 1 Capsule with food or few hours before or after taking other medication once daily. 1 arm group, Participants in this study will receive a daily oral dose of 30 mg Iron for a duration of 90 days. The liposomal formulation is designed to enhance the bioavailability of iron, potentially reducing gastrointestinal side effects. Receives: Dietary Supplement: 30 mg liposomal iron, capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the change in Maternal Hemoglobin Level
Measurement: To assess the efficacy of liposomal iron 30 mg once daily on hemoglobin levels in non-anemic pregnant females, measurement: Hemoglobin (g/dL)
Measured: Baseline and after 90 days of treatment
Secondary outcomes (3)
Measures change in Serum Ferritin Levels to evaluate changes in serum ferritin levels following liposomal iron supplementation.
Measurement: Ferritin (µg/L)
Measured: Baseline and after 90 days of treatment
Assessment of Maternal Gastrointestinal Side Effects, to monitor gastrointestinal side effects associated with liposomal iron supplementation during pregnancy.
Measurement: Incidence of side effects (Count of reported instances)
Measured: Days 30, 60, and 90 of treatment
Compliance Rate with Supplementation, to assess patient compliance with liposomal iron supplementation.
Measurement: Compliance rate (Percentage)
Measured: At each prenatal visit (Days 30, 60, and 90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Nov 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anemia of PregnancyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 714 participants (estimated)
- Target duration
- 90 Days
Sponsor and investigators
- Lead sponsor
- Orchidia pharmaceutical Industries
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MARS-Global
- Responsible party
- Sponsor
- Investigators
- Yasser S El Kassar, Prof. Dr., Principal investigator, Faculty of medicine Alexandria university, obstetrics and gynecology department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669052
- Sponsor's protocol ID
- 00012098
- Acronym
- LITSNPF
- Status last verified
- Oct 2024
- First submitted
- 28 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Currently, it is undecided whether individual participant data (IPD) collected in this study will be shared with other researchers. This decision will be evaluated upon the study's completion
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Iron 30 mg Supplement in Non-anemic Pregnant Females an Observational Study
- ClinicalTrials.gov ID
- NCT06669052
- Acronym / sponsor ID
- LITSNPF / 00012098
- Conditions
- Anemia of Pregnancy, Iron Deficiency Anemia
- Keywords
- 30 mg liposomal irom, non-anemic pregnant females, observational study, hemoglobin level, Second trimester
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 714 participants (estimated)
- Lead sponsor
- Orchidia pharmaceutical IndustriesIndustry (pharma, biotech, devices)
- Collaborators
- MARS-Global
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 1 Nov 2024 (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.
Protocol Summary: Liposomal Iron Supplementation in Non-anemic Pregnant Females This observational study aims to evaluate the efficacy and safety of daily liposomal iron supplementation (30 mg) in non-anemic pregnant women during their second trimester of pregnancy. The study will focus on pregnant females aged 18-45 years with low-risk, singleton pregnancies who are non-anemic (hemoglobin ≥10.5) at 14-16 weeks gestation.
Primary Research Question:
Does daily supplementation with 30 mg liposomal iron effectively maintain maternal hemoglobin levels over 90 days? Measured by: The difference in maternal hemoglobin levels between baseline and after 90 days of treatment in women recruited at 14-16 weeks gestation.
Secondary Research Questions:
What are the effects of liposomal iron supplementation on serum ferritin levels? Measured by: Changes in serum ferritin levels between baseline and after 90 days of treatment.
What is the safety profile of liposomal iron supplementation during pregnancy? Measured by: Maternal gastrointestinal side effects monitored at each prenatal visit (day 30, 60, and 90).
What is the compliance rate with liposomal iron supplementation? Measured by: Participant-reported compliance assessed at each prenatal visit (day 30, 60, and 90).
Participants will:
Receive daily liposomal iron supplementation (30 mg) for 90 days. Attend regular prenatal visits for monitoring at days 30, 60, and 90. Complete questionnaires about compliance and any adverse effects at each visit. Undergo blood tests to measure hemoglobin and serum ferritin levels at baseline and day 90.
This multi-center study will involve 714 participants across 100 sites, with recruitment beginning in November 2024 and study completion expected by July 2025. The study's findings will contribute to understanding the role of liposomal iron supplementation in preventing iron deficiency during pregnancy and its potential advantages over traditional iron supplements in terms of tolerability and compliance.
Detailed description
This observational, prospective study aims to evaluate the safety and efficacy of Liposomal Iron 30 mg supplement in non-anemic pregnant women during the second trimester (gestational weeks 14 to 16). Conducted at approximately 100investigative sites across Egypt, the study targets the enrollment of 714 participants.
The primary objective is to assess the impact of daily supplementation with liposomal iron over a 90-day period on maternal health. The study will monitor participants through routine prenatal visits, where data on adverse effects will be collected alongside routine hemoglobin and serum ferritin measurements.
The study will utilize a Data and Safety Monitoring Board (DSMB) to ensure oversight of participant safety and the integrity of study data. The DSMB will regularly review safety information and study progress, providing recommendations to the sponsor regarding the continuation or termination of the trial if necessary.
Statistical analyses will be performed using methods appropriate for the data collected, ensuring that the results will robustly assess the safety and efficacy of the liposomal iron supplement.
This study is designed to provide critical insights into iron supplementation for pregnant women, addressing a significant public health issue by exploring a formulation that may enhance compliance and reduce gastrointestinal side effects associated with traditional iron supplements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 90 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 arm group, pregnant non-anemic females, second trimester. | – | Dietary Supplement: 30 mg liposomal iron, capsulesLiposomal iron, capsules, 1 Capsule with food or few hours before or after taking other medication once daily. 1 arm group, Participants in this study will receive a daily oral dose of 30 mg Iron for a duration of 90 days. The liposomal formulation is designed to enhance the bioavailability of iron, potentially reducing gastrointestinal side effects. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study will include non-anemic pregnant females > 18 years old taking liposomal iron in non-anemic pregnant females as an iron supplement during 14-16 weeks of pregnancy. The study will be conducted at approximately 100 investigative sites in Egypt. Recruitment will stop when approximately 714 subjects are enrolled.
Key inclusion criteria (5 listed)
- Pregnant females; gestational age from 14 to 16 weeks Age 18-45 years
- Low-risk pregnancy is defined as a pregnancy in which there is no high risk of problems or unfavorable outcomes, and the expectant mother and fetus are typically healthy
- Non-anemic women at the time of recruitment (hemoglobin level not less than 10.5. Hemoglobin measured within 2 or 3 weeks of recruitment
- Singleton pregnancy
- Agree to participate in the study including data collection from medical records and participation in related questionnaires.
Key exclusion criteria (6 listed)
- Inadequate medical records
- Pregnant women living in areas away from the recruitment center
- Had any chronic health problem.
- Women with any form of hereditary anemia including sickle cell anemia, thalassemia, and Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
- History of antepartum bleeding
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 |
|---|---|---|
| 30 mg liposomal iron, capsulesa dietary supplement capsule, of mainly 30 mg liposomal iron, and Vitamin C 70mg, vitamin D3 400IU, vitamin B6 1.75 mcg, Folate 1000 mcg, b=vitamin B12 10 mcg. all in capsulated in 1 Hard gelatin capsule | Dietary supplement | 1 arm group, pregnant non-anemic females, second trimester. |
Primary outcome
Measure the change in Maternal Hemoglobin Level
Time frame: Baseline and after 90 days of treatment
Measurement: To assess the efficacy of liposomal iron 30 mg once daily on hemoglobin levels in non-anemic pregnant females, measurement: Hemoglobin (g/dL)
3 secondary outcomes
Measures change in Serum Ferritin Levels to evaluate changes in serum ferritin levels following liposomal iron supplementation.
Time frame: Baseline and after 90 days of treatment
Assessment of Maternal Gastrointestinal Side Effects, to monitor gastrointestinal side effects associated with liposomal iron supplementation during pregnancy.
Time frame: Days 30, 60, and 90 of treatment
Compliance Rate with Supplementation, to assess patient compliance with liposomal iron supplementation.
Time frame: At each prenatal visit (Days 30, 60, and 90)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2024.
- Individual participant dataSharing planned: Undecided. Currently, it is undecided whether individual participant data (IPD) collected in this study will be shared with other researchers. This decision will be evaluated upon the study's completion
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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.
Yasser S El Kassar, Prof. Dr. principal investigator
Faculty of medicine Alexandria university, obstetrics and gynecology department
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia of Pregnancy and Iron Deficiency Anemia, run by Orchidia pharmaceutical Industries.
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 6 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: status not confirmed, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nada K Rezk, Medical Advisor (+201000071245, nadakamel233@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the change in Maternal Hemoglobin Level (time frame: Baseline and after 90 days of treatment). 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 1 Nov 2024.