Clinical trial NCT06875947: EFFECTS of MORINGA OLEIFERA LEAF POWDERS on HEMATOLOGICAL PROFILES IN PREGNANT WOMEN WITH IRON DEFICIENCY ANAEMIA
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
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
Randomized Controlled Trial
Pregnancy
Nutritional Therapy
Oxidative Stress
Traditional Medicine
Phytotherapy
Lead sponsor: Fakultas Kedokteran Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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, Joglo, 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 Hematocrit (Hct) levels Erythrocyte Indices (MCV, MCH, MCHC) Serum Hepcidin levels (as a biomarker of iron homeostasis) Serum IL-6 (Pro-inflammatory cytokines)

Secondary Outcome Measures:

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.

Principal Investigator:

H. Awie Darwizar, M.D., Sp.OG., D.MAS., MMRS., FIHFAA Email: adarwizar1512@gmail.com Phone: +62 812 2323 132

Eligibility criteria: Inclusion Criteria

1. Demographic Characteristics:

   * Women aged 18-44 years
   * Married, have a husband and/or family
   * Have an ID card
2. Clinical Characteristics:

   * Pregnant with a gestational age of 28 to \<32 weeks
   * 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
3. 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Hemoglobin Levels
timeFrame: Baseline (Day 0) and Day 60
measure: Hematocrit Levels
timeFrame: Baseline (Day 0) and Day 60
measure: Mean Corpuscular Volume (MCV)
timeFrame: Baseline (Day 0) and Day 60
measure: Mean Corpuscular Hemoglobin (MCH)
timeFrame: Baseline (Day 0) and Day 60
measure: Serum Hepcidin Levels
timeFrame: Baseline (Day 0) and Day 60
measure: Serum IL-6 Levels
timeFrame: Baseline (Day 0) and Day 60
measure: Mean Corpuscular Hemoglobin Concentration (MCHC)
timeFrame: Baseline (Day 0) and Day 60
measure: Serum Iron
timeFrame: Baseline (Day 0) and Day 60
Secondary outcomes:
measure: Total Iron Binding Capacity (TIBC)
timeFrame: Baseline (Day 0) and Day 60
measure: Reticulocyte Hemoglobin Content (RET-He)
timeFrame: Baseline (Day 0) and Day 60
measure: Red Cell Distribution Width - Standard Deviation (RDW-SD)
timeFrame: Baseline (Day 0) and Day 60
measure: Red Cell Distribution Width - Coefficient of Variation (RDW-CV)
timeFrame: Baseline (Day 0) and Day 60
measure: Serum IL-1β Levels
timeFrame: Baseline (Day 0) and Day 60
measure: Serum Glutamate Pyruvate Transaminase (SGPT)
timeFrame: Baseline (Day 0) and Day 60
measure: Serum Glutamate Oxaloacetate Transaminase (SGOT)
timeFrame: Baseline (Day 0) and Day 60
measure: Serum Creatinine Levels
timeFrame: Baseline (Day 0) and Day 60
measure: Peripheral Blood Smear Analysis
timeFrame: Baseline (Day 0) and Day 60
Other outcomes:
Locations:
city: Cianjur
country: Indonesia
facility: Pusat Kesehatan Masyarakat (PUSKESMAS)
state: West Java
Study officials:
References:
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