Iron Deficiency Anemia of PregnancyNCT06875947
EFFECTS of MORINGA OLEIFERA LEAF POWDERS on HEMATOLOGICAL PROFILES IN PREGNANT WOMEN WITH IRON DEFICIENCY ANAEMIA
A study testing Moringa Oleifera Leaf Micronized Powders in Capsule and Standard Iron Tablets (Fe + Folic Acid) in people with Iron Deficiency Anemia of Pregnancy and Pregnancy Complications, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
Title: The Effect of Moringa Oleifera Leaf Micronized Powders on Hematological Profile, Hepcidin, and Cytokines (IL-1 and IL-6) in Pregnant Women with Iron Deficiency Anemia Study Description: Iron deficiency anemia is one of the most common health problems affecting pregnant women worldwide, especially in developing… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Iron Deficiency Anemia of Pregnancy, Pregnancy Complications, Inflammation
- What is being tested?
- Moringa Oleifera Leaf Micronized Powders in Capsule and Standard Iron Tablets (Fe + Folic Acid)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteIndonesia
- Study dates
- 23 May 2025to 31 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Demographic Characteristics:
- Women aged 18-44 years
- Married, have a husband and/or family
- Have an ID card
- Clinical Characteristics:
- Pregnant with a gestational age of 28 to <32 weeks
Show all 15Show fewer
- Live single fetus
- Hemoglobin (Hb) 7 - < 11 g/dl
- No congenital abnormalities
- No complication (DM, infection, genetic disease) based on history taking, clinical signs and symptoms and treatment history.
- Parity < 4
- Geographical/Administrative Characteristics:
- The study subjects (pregnant women) were located in the working area of the health facility where the study was conducted.
- Health Facility where the study was conducted.
- Come to the health facility independently or by referral.
Who cannot join
- Pregnant women with high risk who dropped out or could not be followed up and pregnant women who gave birth prematurely.
- Allergy to Moringa Oleifera leaf micronized powders
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Pusat Kesehatan Masyarakat (PUSKESMAS)
Cianjur, West Java, 43211
About this study
Official title: EFFECTS of MORINGA OLEIFERA LEAF MICRONIZED POWDERS on HEMATOLOGICAL PROFILES, PERIPHERAL BLOOD SMEAR, HEPCIDIN, AND CYTOKINES (IL-1 DAN IL-6) OF PREGNANT WOMEN WITH IRON DEFICIENCY ANAEMIA
Title: The Effect of Moringa Oleifera Leaf Micronized Powders on Hematological Profile, Hepcidin, and Cytokines (IL-1 and IL-6) in Pregnant Women with Iron Deficiency Anemia
Study Description:
Read more
Iron deficiency anemia is one of the most common health problems affecting pregnant women worldwide, especially in developing countries like Indonesia. This condition can cause serious complications for both mothers and babies, such as premature birth, low birth weight, and increased risk of maternal mortality. Despite the availability of iron supplements as a standard treatment, many women experience side effects such as nausea, constipation, and poor absorption, which often lead to low adherence to the medication.
This clinical study aims to explore the potential of Moringa Oleifera leaf micronized powders (finely ground Moringa leaf powder) as a natural, plant-based supplement to help improve hemoglobin levels in pregnant women suffering from iron deficiency anemia. Moringa leaves are known for their rich nutritional content, including iron, antioxidants, and anti-inflammatory compounds, making them a promising alternative to traditional iron supplements.
The study will involve 72 pregnant women between 28-32 weeks of gestation diagnosed with iron deficiency anemia. Participants will be randomly assigned into two groups:
Group A will receive Moringa leaf capsules along with standard iron tablets. Group B will receive only standard iron tablets as the control group. The intervention will last for 60 days, during which participants will undergo regular blood tests to measure hemoglobin levels, iron status markers (hepcidin, TIBC), and inflammatory cytokines (IL-1 and IL-6). The study will also monitor the safety of Moringa leaf supplements, including liver and kidney functions.
Hypothesis: The study hypothesizes that adding Moringa Oleifera leaf micronized powders to standard iron therapy will significantly improve hemoglobin levels, iron status, and reduce inflammation in pregnant women with iron deficiency anemia compared to iron tablets alone.
This research is expected to provide scientific evidence supporting the use of Moringa leaves as a safe, effective, and affordable alternative therapy to help combat iron deficiency anemia during pregnancy.
Read the detailed description
Title: The Effect of Moringa Oleifera Leaf Micronized Powders on Hematological Profile, Hepcidin, and Cytokines (IL-1 and IL-6) in Pregnant Women with Iron Deficiency Anemia
Background and Rationale:Iron deficiency anemia (IDA) remains a significant public health challenge during pregnancy, especially in low-to-middle-income countries. The condition affects both maternal and fetal health, increasing the risk of preterm delivery, low birth weight, and maternal mortality. Despite the widespread use of conventional iron supplements, the prevalence of anemia in pregnant women in Indonesia consistently exceeds 40% over the last two decades (WHO, 2022). Conventional iron tablets often result in gastrointestinal side effects, poor adherence, and limited bioavailability, highlighting the urgent need for alternative therapies.
Moringa Oleifera leaves have been widely recognized for their high nutritional value, containing essential micronutrients such as iron, calcium, vitamin C, and antioxidants. Emerging studies suggest that Moringa leaves have hematopoietic, anti-inflammatory, and antioxidant properties, making them a promising adjunctive therapy for iron deficiency anemia. However, high-quality clinical trials evaluating their efficacy and safety in pregnant women are still limited.
This randomized controlled trial (RCT) will investigate whether Moringa Oleifera Leaf Micronized Powders (MOLMP) combined with standard iron supplementation improves hematological parameters and reduces inflammation compared to iron supplementation alone in pregnant women with IDA.
Study Design:
Type: Open-labeled, randomized controlled trial (RCT) Allocation: 1:1 Randomized Allocation Intervention Model: Parallel Groups Masking: None (Open Label) Study Duration: 60 Days Sample Size: 72 participants (36 in each group) Study Site: Community Health Centers (Puskesmas Muka, Cianjur Kota, Cijedil, Karang Tengah) in Cianjur, West Java, Indonesia
Intervention Groups:
Group A (Intervention): Moringa Oleifera Leaf Micronized Powders (MOLMP) capsules (3x650 mg/day) + standard iron tablets (Fe tablet 60 mg + Folic Acid 400 mcg/day) Group B (Control): Standard iron tablets (Fe tablet 60 mg + Folic Acid 400 mcg/day) only
The Moringa Oleifera powder will be processed through micronization technology to increase bioavailability and optimize nutrient absorption.
Primary Outcome Measures:
Hemoglobin (Hb) levels
Secondary Outcome Measures:
Hematocrit (Hct) levels Erythrocyte Indices (MCV, MCH, MCHC) Serum Hepcidin levels (as a biomarker of iron homeostasis) Serum IL-6 (Pro-inflammatory cytokines) Serum IL-1β (Pro-inflammatory cytokines) Peripheral Blood Smear Analysis Total Iron Binding Capacity (TIBC) Reticulocyte Hemoglobin Content (RET-He) Red Cell Distribution Width (RDW-SD, RDW-CV) Liver Function Tests (SGOT, SGPT) Kidney Function Tests (Creatinine levels)
Methodology:
Participants will undergo screening and baseline laboratory tests on Day 0, followed by random allocation into two groups. All participants will receive standard antenatal care. Intervention products will be administered daily under self-administration supervision for 60 days. Compliance will be monitored through weekly visits, phone reminders, and supplement consumption diaries.
Blood samples will be collected at baseline (Day 0), and Day 60 to assess hematological parameters, iron status markers, and inflammatory biomarkers. Safety assessments will be conducted throughout the study to monitor liver and kidney function.
Randomization and Allocation Concealment:
Random allocation will be conducted using computer-generated random numbers. Participants will be assigned to either Group A or Group B with a 1:1 ratio.
Statistical Analysis Plan:
Baseline characteristics will be compared using Chi-square tests for categorical variables and Independent t-tests or Mann-Whitney U tests for continuous variables.
Primary outcomes will be analyzed using Repeated Measures ANOVA or Mixed Effects Models to evaluate changes over time.
Secondary outcomes will be analyzed using ANCOVA adjusted for baseline values and potential confounders.
Statistical significance will be set at p < 0.05.
Ethical Considerations:
The study has received ethical approval from the Ethics Committee of Universitas Padjadjaran (No: 159/UN6.KEP/EC/2025). Written informed consent will be obtained from all participants prior to enrolment. All procedures will comply with ICH-GCP (Good Clinical Practice) guidelines and the Declaration of Helsinki.
Risk and Safety Monitoring:
Potential side effects of Moringa Oleifera supplements include hypotension and hypoglycemia. Adverse events will be recorded using standardized Adverse Event Report Forms. Liver and kidney function will be closely monitored.
Data Confidentiality:
Participant data will be anonymized using unique identification codes. All information will be stored in encrypted databases and retained for a minimum of 10 years.
Expected Outcomes:
It is anticipated that the addition of Moringa Oleifera Leaf Micronized Powders will result in:
A significant increase in hemoglobin levels Improved iron homeostasis through reduced hepcidin levels Lower levels of pro-inflammatory cytokines (IL-1 and IL-6) Minimal side effects compared to standard iron tablets
Significance of Study:
If proven effective, Moringa Oleifera leaf powder could serve as a safe, natural, and cost-effective alternative to improve iron deficiency anemia in pregnant women, especially in resource-limited settings.
Due to an extension of the participant recruitment period, the anticipated timelines of the study have been updated. Participant recruitment is expected to continue until February 2026. The primary completion date defined as the date when the final participant receives the intervention and primary outcome data are collected, is anticipated to be April 2026. Final data collection for all study outcomes is anticipated to be completed by May 2026.
Principal Investigator:
- Awie Darwizar, M.D., Sp.OG., D.MAS., MMRS., FIHFAA Email: adarwizar1512@gmail.com Phone: +62 812 2323 132
- Conditions
- Iron Deficiency Anemia of Pregnancy, Pregnancy Complications, Inflammation, Moringa Oleifera, Cytokines (IL-1, IL-6), Hepcidin
- Being tested
- Moringa Oleifera Leaf Micronized Powders in Capsule, Standard Iron Tablets (Fe + Folic Acid)
- Keywords
- Iron Deficiency Anemia, Pregnancy Complications, Hematologic, Moringa oleifera, Dietary Supplements, Hepcidins, Interleukin-1, Interleukin-6, Erythrocyte Indices, Randomized Controlled Trial, Pregnancy, Nutritional Therapy, Oxidative Stress, Traditional Medicine, Phytotherapy
- Medical subject headings
- Pregnancy Complications, Inflammation, Anemia, Iron-Deficiency, Pregnancy Complications, Hematologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa Oleifera Leaf Micronized Powders in CapsuleDietary supplement
Also called Bubuk Halus Daun Kelor
Moringa Oleifera Leaf Micronized Powders (MOLMP)
Source: Derived from finely ground Moringa Oleifera leaves using micronization technology to enhance bioavailability.
Dosage: 650 mg per capsule, taken three times daily (1,950 mg/day). Administration Duration: 60 days. Monitoring: Self-administration under weekly compliance checks.
Standard Iron Tablets (Fe + Folic Acid)Drug
Also called Tablet Tambah Darah
Dosage: One tablet containing 60 mg iron and 400 mcg folic acid per day. Administration Duration: 60 days.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - Moringa Oleifera Leaf Micronized Powders + Standard Iron Tablets | Experimental | Participants in this group will receive Moringa Oleifera Leaf Micronized Powders (MOLMP) 3×650 mg/day in capsule form, combined with standard iron tablets (Fe tablet 60 mg + Folic Acid 400 mcg/day) for 60 days.
This intervention aims to evaluate the combined effect of Moringa Oleifera and standard iron supplements on hematological parameters, iron homeostasis, and inflammatory markers in pregnant women with iron deficiency anemia. Receives: Dietary Supplement: Moringa Oleifera Leaf Micronized Powders in Capsule; Drug: Standard Iron Tablets (Fe + Folic Acid) |
| Active Comparator: Control Group - Standard Iron Tablets Only | Active comparator | Participants in this group will receive only standard iron tablets (Fe tablet 60 mg + Folic Acid 400 mcg/day) for 60 days.
This arm serves as the control group to compare the effectiveness of standard iron therapy alone versus the combined intervention (MOLMP + Iron Tablets). Receives: Drug: Standard Iron Tablets (Fe + Folic Acid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin Levels
Measurement of hemoglobin concentration (g/dL) in venous blood to assess the improvement of anemia status in response to intervention. Hemoglobin is the primary indicator for anemia diagnosis and treatment effectiveness.
Measured: Baseline (Day 0) and Day 60
Secondary outcomes (16)
Total Iron Binding Capacity (TIBC)
Measurement of the blood's capacity to bind iron with transferrin (µg/dL), indicating iron availability and iron saturation.
Measured: Baseline (Day 0) and Day 60
Reticulocyte Hemoglobin Content (RET-He)
Measurement of hemoglobin content in reticulocytes (pg), reflecting recent iron availability for erythropoiesis.
Measured: Baseline (Day 0) and Day 60
Red Cell Distribution Width - Standard Deviation (RDW-SD)
Measurement of the variation in red blood cell size (fL), indicating anisocytosis related to iron deficiency anemia.
Measured: Baseline (Day 0) and Day 60
Red Cell Distribution Width - Coefficient of Variation (RDW-CV)
Measurement of the coefficient of variation of red blood cell size distribution (%), providing additional information on anisocytosis severity.
Measured: Baseline (Day 0) and Day 60
Serum IL-1β Levels
Measurement of serum interleukin-1 beta (IL-1β) concentration (pg/mL) to evaluate systemic inflammatory response.
Measured: Baseline (Day 0) and Day 60
Serum Glutamate Pyruvate Transaminase (SGPT)
Measurement of SGPT levels (U/L) to assess liver function and monitor potential hepatotoxicity of the intervention.
Measured: Baseline (Day 0) and Day 60
Serum Glutamate Oxaloacetate Transaminase (SGOT)
Measurement of SGOT levels (U/L) to evaluate liver function and detect potential hepatotoxicity of the intervention.
Measured: Baseline (Day 0) and Day 60
Serum Creatinine Levels
Measurement of serum creatinine (mg/dL) to assess kidney function and monitor potential nephrotoxicity of the intervention.
Measured: Baseline (Day 0) and Day 60
Peripheral Blood Smear Analysis
Microscopic evaluation of red blood cell morphology to detect changes such as hypochromia, microcytosis, anisocytosis, and poikilocytosis. This analysis provides supportive evidence for anemia classification and intervention effects.
Measured: Baseline (Day 0) and Day 60
Hematocrit Levels
Proportion of red blood cells to the total blood volume (%) to evaluate anemia severity and treatment response. Hematocrit indicates the volume percentage of red blood cells in blood samples.
Measured: Baseline (Day 0) and Day 60
Mean Corpuscular Volume (MCV)
Measurement of the average size of red blood cells (fL) to classify anemia as microcytic, normocytic, or macrocytic, which reflects the effect of the intervention on red cell morphology.
Measured: Baseline (Day 0) and Day 60
Mean Corpuscular Hemoglobin (MCH)
Measurement of the average concentration of hemoglobin in a given volume of red blood cells (g/dL), reflecting the effect of intervention on hemoglobin saturation within red blood cells.
Measured: Baseline (Day 0) and Day 60
Mean Corpuscular Hemoglobin Concentration (MCHC)
Measurement of the average concentration of hemoglobin in a given volume of red blood cells (g/dL). MCHC reflects the hemoglobin saturation within erythrocytes and is used to assess the severity and type of anemia. Changes in MCHC indicate improvements in iron availability and erythropoiesis in response to supplementation.
Measured: Baseline (Day 0) and Day 60
Serum Iron
Serum Iron represents the actual circulating iron available for erythropoiesis (red blood cell production). In IDA, serum iron levels decrease significantly due to depleted iron stores. Serum iron helps quantify the degree of iron deficiency and supports a more precise biochemical assessment of IDA when used alongside TIBC.
Measured: Baseline (Day 0) and Day 60
Serum Hepcidin Levels
Quantification of serum hepcidin (ng/mL) as a biomarker of iron homeostasis and iron absorption regulation. Hepcidin levels will help assess the intervention's role in modulating iron metabolism.
Measured: Baseline (Day 0) and Day 60
Serum IL-6 Levels
Measurement of interleukin-6 (IL-6) concentration (pg/mL) in venous blood to evaluate the intervention's effect on systemic inflammation, which plays a critical role in iron metabolism.
Measured: Baseline (Day 0) and Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start23 May 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Iron Deficiency 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This clinical study uses a Parallel Assignment Model, where participants are randomly allocated into two independent groups. Group A (Intervention) will receive Moringa Oleifera Leaf Micronized Powders (MOLMP) capsules combined with standard iron tablets, while Group B (Control) will receive standard iron tablets alone. Both groups will be followed simultaneously over a 60-day intervention period, with regular monitoring of hematological parameters, iron biomarkers, and inflammatory cytokines. This model allows direct comparison between the intervention and control groups to assess the efficacy and safety of Moringa Oleifera in improving iron deficiency anemia outcomes during pregnancy.
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H. Awie Darwizar, M.D., Sp.OG., D.MAS., MMRS., FIHFAA, Universitas Padjadjaran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875947
- Sponsor's protocol ID
- 159/UN.6.KEP/EC/2025
- Status last verified
- Feb 2026
- First submitted
- 9 Mar 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan Description : De-identified individual participant data (IPD) will be shared upon reasonable request for research purposes. The data will include: * Primary outcomes: Hemoglobin * Secondary outcomes: Hematocrit, erythrocyte indices, Hepcidin, IL-6, Peripheral blood smear, iron metabolism markers ( TIBC), inflammatory markers (IL-1) * Additional parameters: RDW-SD, RDW-CV, Ret-He, SGOT, SGPT, creatinine Data will be stripped of all personal identifiers to ensure confidentiality and comply with ethical standards.
Publications
Pareek A, Pant M, Gupta MM, Kashania P, Ratan Y, Jain V, Pareek A, Chuturgoon AA. Moringa oleifera: An Updated Comprehensive Review of Its Pharmacological Activities, Ethnomedicinal, Phytopharmaceutical Formulation, Clinical, Phytochemical, and Toxicological Aspects. Int J Mol Sci. 2023 Jan 20;24(3):2098. doi: 10.3390/ijms24032098.
PubMed 36768420Stohs SJ, Hartman MJ. Review of the Safety and Efficacy of Moringa oleifera. Phytother Res. 2015 Jun;29(6):796-804. doi: 10.1002/ptr.5325. Epub 2015 Mar 24.
PubMed 25808883Weiss G, Ganz T, Goodnough LT. Anemia of inflammation. Blood. 2019 Jan 3;133(1):40-50. doi: 10.1182/blood-2018-06-856500. Epub 2018 Nov 6.
PubMed 30401705de Barros MC, Silva AGB, Souza TGDS, Chagas CA, Machado JCB, Ferreira MRA, Soares LAL, Xavier VL, de Araujo LCC, Borba EFO, da Silva TG, Alves RRV, Coelho LCBB, de Oliveira AM, Napoleao TH, Paiva PMG. Evaluation of acute toxicity, 28-day repeated dose toxicity, and genotoxicity of Moringa oleifera leaves infusion and powder. J Ethnopharmacol. 2022 Oct 5;296:115504. doi: 10.1016/j.jep.2022.115504. Epub 2022 Jun 26.
PubMed 35760258Vyoral D, Jiri Petrak. Therapeutic potential of hepcidin - the master regulator of iron metabolism. Pharmacol Res. 2017 Jan;115:242-254. doi: 10.1016/j.phrs.2016.11.010. Epub 2016 Nov 17.
PubMed 27867027
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS of MORINGA OLEIFERA LEAF MICRONIZED POWDERS on HEMATOLOGICAL PROFILES, PERIPHERAL BLOOD SMEAR, HEPCIDIN, AND CYTOKINES (IL-1 DAN IL-6) OF PREGNANT WOMEN WITH IRON DEFICIENCY ANAEMIA
- ClinicalTrials.gov ID
- NCT06875947
- Acronym / sponsor ID
- 159/UN.6.KEP/EC/2025
- Conditions
- Iron Deficiency Anemia of Pregnancy, Pregnancy Complications, Inflammation, Moringa Oleifera, Cytokines (IL-1, IL-6), Hepcidin
- Keywords
- Iron Deficiency Anemia, Pregnancy Complications, Hematologic, Moringa oleifera, Dietary Supplements, Hepcidins, Interleukin-1, Interleukin-6, Erythrocyte Indices
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 23 May 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 13 Mar 2025 (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.
Title: The Effect of Moringa Oleifera Leaf Micronized Powders on Hematological Profile, Hepcidin, and Cytokines (IL-1 and IL-6) in Pregnant Women with Iron Deficiency Anemia
Study Description:
Iron deficiency anemia is one of the most common health problems affecting pregnant women worldwide, especially in developing countries like Indonesia. This condition can cause serious complications for both mothers and babies, such as premature birth, low birth weight, and increased risk of maternal mortality. Despite the availability of iron supplements as a standard treatment, many women experience side effects such as nausea, constipation, and poor absorption, which often lead to low adherence to the medication.
This clinical study aims to explore the potential of Moringa Oleifera leaf micronized powders (finely ground Moringa leaf powder) as a natural, plant-based supplement to help improve hemoglobin levels in pregnant women suffering from iron deficiency anemia. Moringa leaves are known for their rich nutritional content, including iron, antioxidants, and anti-inflammatory compounds, making them a promising alternative to traditional iron supplements.
The study will involve 72 pregnant women between 28-32 weeks of gestation diagnosed with iron deficiency anemia. Participants will be randomly assigned into two groups:
Group A will receive Moringa leaf capsules along with standard iron tablets. Group B will receive only standard iron tablets as the control group. The intervention will last for 60 days, during which participants will undergo regular blood tests to measure hemoglobin levels, iron status markers (hepcidin, TIBC), and inflammatory cytokines (IL-1 and IL-6). The study will also monitor the safety of Moringa leaf supplements, including liver and kidney functions.
Hypothesis: The study hypothesizes that adding Moringa Oleifera leaf micronized powders to standard iron therapy will significantly improve hemoglobin levels, iron status, and reduce inflammation in pregnant women with iron deficiency anemia compared to iron tablets alone.
This research is expected to provide scientific evidence supporting the use of Moringa leaves as a safe, effective, and affordable alternative therapy to help combat iron deficiency anemia during pregnancy.
Detailed description
Title: The Effect of Moringa Oleifera Leaf Micronized Powders on Hematological Profile, Hepcidin, and Cytokines (IL-1 and IL-6) in Pregnant Women with Iron Deficiency Anemia
Background and Rationale:Iron deficiency anemia (IDA) remains a significant public health challenge during pregnancy, especially in low-to-middle-income countries. The condition affects both maternal and fetal health, increasing the risk of preterm delivery, low birth weight, and maternal mortality. Despite the widespread use of conventional iron supplements, the prevalence of anemia in pregnant women in Indonesia consistently exceeds 40% over the last two decades (WHO, 2022). Conventional iron tablets often result in gastrointestinal side effects, poor adherence, and limited bioavailability, highlighting the urgent need for alternative therapies.
Moringa Oleifera leaves have been widely recognized for their high nutritional value, containing essential micronutrients such as iron, calcium, vitamin C, and antioxidants. Emerging studies suggest that Moringa leaves have hematopoietic, anti-inflammatory, and antioxidant properties, making them a promising adjunctive therapy for iron deficiency anemia. However, high-quality clinical trials evaluating their efficacy and safety in pregnant women are still limited.
This randomized controlled trial (RCT) will investigate whether Moringa Oleifera Leaf Micronized Powders (MOLMP) combined with standard iron supplementation improves hematological parameters and reduces inflammation compared to iron supplementation alone in pregnant women with IDA.
Study Design:
Type: Open-labeled, randomized controlled trial (RCT) Allocation: 1:1 Randomized Allocation Intervention Model: Parallel Groups Masking: None (Open Label) Study Duration: 60 Days Sample Size: 72 participants (36 in each group) Study Site: Community Health Centers (Puskesmas Muka, Cianjur Kota, Cijedil, Karang Tengah) in Cianjur, West Java, Indonesia
Intervention Groups:
Group A (Intervention): Moringa Oleifera Leaf Micronized Powders (MOLMP) capsules (3x650 mg/day) + standard iron tablets (Fe tablet 60 mg + Folic Acid 400 mcg/day) Group B (Control): Standard iron tablets (Fe tablet 60 mg + Folic Acid 400 mcg/day) only
The Moringa Oleifera powder will be processed through micronization technology to increase bioavailability and optimize nutrient absorption.
Primary Outcome Measures:
Hemoglobin (Hb) levels
Secondary Outcome Measures:
Hematocrit (Hct) levels Erythrocyte Indices (MCV, MCH, MCHC) Serum Hepcidin levels (as a biomarker of iron homeostasis) Serum IL-6 (Pro-inflammatory cytokines) Serum IL-1β (Pro-inflammatory cytokines) Peripheral Blood Smear Analysis Total Iron Binding Capacity (TIBC) Reticulocyte Hemoglobin Content (RET-He) Red Cell Distribution Width (RDW-SD, RDW-CV) Liver Function Tests (SGOT, SGPT) Kidney Function Tests (Creatinine levels)
Methodology:
Participants will undergo screening and baseline laboratory tests on Day 0, followed by random allocation into two groups. All participants will receive standard antenatal care. Intervention products will be administered daily under self-administration supervision for 60 days. Compliance will be monitored through weekly visits, phone reminders, and supplement consumption diaries.
Blood samples will be collected at baseline (Day 0), and Day 60 to assess hematological parameters, iron status markers, and inflammatory biomarkers. Safety assessments will be conducted throughout the study to monitor liver and kidney function.
Randomization and Allocation Concealment:
Random allocation will be conducted using computer-generated random numbers. Participants will be assigned to either Group A or Group B with a 1:1 ratio.
Statistical Analysis Plan:
Baseline characteristics will be compared using Chi-square tests for categorical variables and Independent t-tests or Mann-Whitney U tests for continuous variables.
Primary outcomes will be analyzed using Repeated Measures ANOVA or Mixed Effects Models to evaluate changes over time.
Secondary outcomes will be analyzed using ANCOVA adjusted for baseline values and potential confounders.
Statistical significance will be set at p < 0.05.
Ethical Considerations:
The study has received ethical approval from the Ethics Committee of Universitas Padjadjaran (No: 159/UN6.KEP/EC/2025). Written informed consent will be obtained from all participants prior to enrolment. All procedures will comply with ICH-GCP (Good Clinical Practice) guidelines and the Declaration of Helsinki.
Risk and Safety Monitoring:
Potential side effects of Moringa Oleifera supplements include hypotension and hypoglycemia. Adverse events will be recorded using standardized Adverse Event Report Forms. Liver and kidney function will be closely monitored.
Data Confidentiality:
Participant data will be anonymized using unique identification codes. All information will be stored in encrypted databases and retained for a minimum of 10 years.
Expected Outcomes:
It is anticipated that the addition of Moringa Oleifera Leaf Micronized Powders will result in:
A significant increase in hemoglobin levels Improved iron homeostasis through reduced hepcidin levels Lower levels of pro-inflammatory cytokines (IL-1 and IL-6) Minimal side effects compared to standard iron tablets
Significance of Study:
If proven effective, Moringa Oleifera leaf powder could serve as a safe, natural, and cost-effective alternative to improve iron deficiency anemia in pregnant women, especially in resource-limited settings.
Due to an extension of the participant recruitment period, the anticipated timelines of the study have been updated. Participant recruitment is expected to continue until February 2026. The primary completion date defined as the date when the final participant receives the intervention and primary outcome data are collected, is anticipated to be April 2026. Final data collection for all study outcomes is anticipated to be completed by May 2026.
Principal Investigator:
- Awie Darwizar, M.D., Sp.OG., D.MAS., MMRS., FIHFAA Email: adarwizar1512@gmail.com Phone: +62 812 2323 132
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This clinical study uses a Parallel Assignment Model, where participants are randomly allocated into two independent groups. Group A (Intervention) will receive Moringa Oleifera Leaf Micronized Powders (MOLMP) capsules combined with standard iron tablets, while Group B (Control) will receive standard iron tablets alone. Both groups will be followed simultaneously over a 60-day intervention period, with regular monitoring of hematological parameters, iron biomarkers, and inflammatory cytokines. This model allows direct comparison between the intervention and control groups to assess the efficacy and safety of Moringa Oleifera in improving iron deficiency anemia outcomes during pregnancy.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - Moringa Oleifera Leaf Micronized Powders + Standard Iron Tablets | Experimental | Dietary Supplement: Moringa Oleifera Leaf Micronized Powders in Capsule, Drug: Standard Iron Tablets (Fe + Folic Acid)Participants in this group will receive Moringa Oleifera Leaf Micronized Powders (MOLMP) 3×650 mg/day in capsule form, combined with standard iron tablets (Fe tablet 60 mg + Folic Acid 400 mcg/day) for 60 days. This intervention aims to evaluate the combined effect of Moringa Oleifera and standard iron supplements on hematological parameters, iron homeostasis, and inflammatory markers in pregnant women with iron deficiency anemia. |
| Active Comparator: Control Group - Standard Iron Tablets Only | Active comparator | Drug: Standard Iron Tablets (Fe + Folic Acid)Participants in this group will receive only standard iron tablets (Fe tablet 60 mg + Folic Acid 400 mcg/day) for 60 days. This arm serves as the control group to compare the effectiveness of standard iron therapy alone versus the combined intervention (MOLMP + Iron Tablets). |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Demographic Characteristics:
- Clinical Characteristics:
- Geographical/Administrative Characteristics:
- Health Facility where the study was conducted.
- Come to the health facility independently or by referral.
Key exclusion criteria (2 listed)
- Pregnant women with high risk who dropped out or could not be followed up and pregnant women who gave birth prematurely.
- Allergy to Moringa Oleifera leaf micronized powders
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 |
|---|---|---|
| Moringa Oleifera Leaf Micronized Powders in CapsuleAlso: Bubuk Halus Daun KelorMoringa Oleifera Leaf Micronized Powders (MOLMP) Source: Derived from finely ground Moringa Oleifera leaves using micronization technology to enhance bioavailability. Dosage: 650 mg per capsule, taken three times daily (1,950 mg/day). Administration Duration: 60 days. Monitoring: Self-administration under weekly compliance checks. | Dietary supplement | Intervention Group - Moringa Oleifera Leaf Micronized Powders + Standard Iron Tablets |
| Standard Iron Tablets (Fe + Folic Acid)Also: Tablet Tambah DarahDosage: One tablet containing 60 mg iron and 400 mcg folic acid per day. Administration Duration: 60 days. | Drug | Active Comparator: Control Group - Standard Iron Tablets Only, Intervention Group - Moringa Oleifera Leaf Micronized Powders + Standard Iron Tablets |
Primary outcome
Hemoglobin Levels
Time frame: Baseline (Day 0) and Day 60
Measurement of hemoglobin concentration (g/dL) in venous blood to assess the improvement of anemia status in response to intervention. Hemoglobin is the primary indicator for anemia diagnosis and treatment effectiveness.
16 secondary outcomes
Total Iron Binding Capacity (TIBC)
Time frame: Baseline (Day 0) and Day 60
Reticulocyte Hemoglobin Content (RET-He)
Time frame: Baseline (Day 0) and Day 60
Red Cell Distribution Width - Standard Deviation (RDW-SD)
Time frame: Baseline (Day 0) and Day 60
Red Cell Distribution Width - Coefficient of Variation (RDW-CV)
Time frame: Baseline (Day 0) and Day 60
Serum IL-1β Levels
Time frame: Baseline (Day 0) and Day 60
Serum Glutamate Pyruvate Transaminase (SGPT)
Time frame: Baseline (Day 0) and Day 60
Serum Glutamate Oxaloacetate Transaminase (SGOT)
Time frame: Baseline (Day 0) and Day 60
Serum Creatinine Levels
Time frame: Baseline (Day 0) and Day 60
Peripheral Blood Smear Analysis
Time frame: Baseline (Day 0) and Day 60
Hematocrit Levels
Time frame: Baseline (Day 0) and Day 60
Mean Corpuscular Volume (MCV)
Time frame: Baseline (Day 0) and Day 60
Mean Corpuscular Hemoglobin (MCH)
Time frame: Baseline (Day 0) and Day 60
Mean Corpuscular Hemoglobin Concentration (MCHC)
Time frame: Baseline (Day 0) and Day 60
Serum Iron
Time frame: Baseline (Day 0) and Day 60
Serum Hepcidin Levels
Time frame: Baseline (Day 0) and Day 60
Serum IL-6 Levels
Time frame: Baseline (Day 0) and Day 60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Background: PubMed 36768420Pareek A, Pant M, Gupta MM, Kashania P, Ratan Y, Jain V, Pareek A, Chuturgoon AA. Moringa oleifera: An Updated Comprehensive Review of Its Pharmacological Activities, Ethnomedicinal, Phytopharmaceutical Formulation, Clinical, Phytochemical, and Toxicological Aspects. Int J Mol Sci. 2023 Jan 20;24(3):2098. doi: 10.3390/ijms24032098.
- Background: PubMed 25808883Stohs SJ, Hartman MJ. Review of the Safety and Efficacy of Moringa oleifera. Phytother Res. 2015 Jun;29(6):796-804. doi: 10.1002/ptr.5325. Epub 2015 Mar 24.
- Background: PubMed 30401705Weiss G, Ganz T, Goodnough LT. Anemia of inflammation. Blood. 2019 Jan 3;133(1):40-50. doi: 10.1182/blood-2018-06-856500. Epub 2018 Nov 6.
- Background: PubMed 35760258de Barros MC, Silva AGB, Souza TGDS, Chagas CA, Machado JCB, Ferreira MRA, Soares LAL, Xavier VL, de Araujo LCC, Borba EFO, da Silva TG, Alves RRV, Coelho LCBB, de Oliveira AM, Napoleao TH, Paiva PMG. Evaluation of acute toxicity, 28-day repeated dose toxicity, and genotoxicity of Moringa oleifera leaves infusion and powder. J Ethnopharmacol. 2022 Oct 5;296:115504. doi: 10.1016/j.jep.2022.115504. Epub 2022 Jun 26.
- Background: PubMed 27867027Vyoral D, Jiri Petrak. Therapeutic potential of hepcidin - the master regulator of iron metabolism. Pharmacol Res. 2017 Jan;115:242-254. doi: 10.1016/j.phrs.2016.11.010. Epub 2016 Nov 17.
- Individual participant dataSharing planned: Yes. Plan Description : De-identified individual participant data (IPD) will be shared upon reasonable request for research purposes. The data will include: * Primary outcomes: Hemoglobin * Secondary outcomes: Hematocrit, erythrocyte indices, Hepcidin, IL-6, Peripheral blood smear, iron metabolism markers ( TIBC), inflammatory markers (IL-1) * Additional parameters: RDW-SD, RDW-CV, Ret-He, SGOT, SGPT, creatinine Data will be stripped of all personal identifiers to ensure confidentiality and comply with ethical standards.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moringa Oleifera Leaf Micronized Powders in Capsule and Standard Iron Tablets (Fe + Folic Acid) in people with Iron Deficiency Anemia of Pregnancy and Pregnancy Complications, run by Universitas Padjadjaran at 1 site in Indonesia.
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 15 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 3 Mar 2026. 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 Indonesia. 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?
This study is still under way. Results are not available in the source record yet.
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?
Hemoglobin Levels (time frame: Baseline (Day 0) and Day 60). 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 NCT06875947, which also lists 5 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 3 Mar 2026.