EFFECTS of MORINGA OLEIFERA LEAF POWDERS on HEMATOLOGICAL PROFILES IN PREGNANT WOMEN WITH IRON DEFICIENCY ANAEMIA

NCT06875947 | Active Not Recruiting DMC

• 1 other identifier: 159/UN.6.KEP/EC/2025
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day 0) and Day 60

Secondary Outcomes (16)

• Total Iron Binding Capacity (TIBC)

  Baseline (Day 0) and Day 60

• Reticulocyte Hemoglobin Content (RET-He)

  Baseline (Day 0) and Day 60

• Red Cell Distribution Width - Standard Deviation (RDW-SD)

  Baseline (Day 0) and Day 60

• Red Cell Distribution Width - Coefficient of Variation (RDW-CV)

  Baseline (Day 0) and Day 60

• Serum IL-1β Levels

  Baseline (Day 0) and Day 60

Study Arms (2)

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.

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).

Drug: Standard Iron Tablets (Fe + Folic Acid)

Interventions

Moringa Oleifera Leaf Micronized Powders in Capsule DIETARY_SUPPLEMENT

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.

Also known as: Bubuk Halus Daun Kelor

Intervention Group - Moringa Oleifera Leaf Micronized Powders + Standard Iron Tablets

Standard Iron Tablets (Fe + Folic Acid) DRUG

Dosage: One tablet containing 60 mg iron and 400 mcg folic acid per day. Administration Duration: 60 days.

Also known as: Tablet Tambah Darah

Active Comparator: Control Group - Standard Iron Tablets Only; Intervention Group - Moringa Oleifera Leaf Micronized Powders + Standard Iron Tablets

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Pusat Kesehatan Masyarakat (PUSKESMAS)

Cianjur, West Java, 43211, Indonesia

Location

Related Publications (5)

• 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.

  PMID: 36768420 BACKGROUND

• Stohs 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.

  PMID: 25808883 BACKGROUND

• Weiss 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.

  PMID: 30401705 BACKGROUND

• de 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.

  PMID: 35760258 BACKGROUND

• Vyoral 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.

  PMID: 27867027 BACKGROUND

MeSH Terms

Conditions

Pregnancy Complications; Inflammation; Anemia, Iron-Deficiency; Pregnancy Complications, Hematologic

Interventions

Capsules; Folic Acid

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study will be conducted without blinding, meaning that both the participants and researchers will be aware of the treatment assignments. This approach is chosen to facilitate close monitoring of adherence, safety, and any potential side effects during the intervention period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Obstetrics and Gynecology

Model Details: 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.

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 13, 2025
• Study Start: May 23, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting documents will be available 6 months after publication of study results and will remain accessible for 5 years.
• Access Criteria: Researchers affiliated with recognized academic or healthcare institutions may submit a formal request to access the data. Applications must be sent to the Principal Investigator at adarwizar1512@gmail.com. Requests will be reviewed to ensure compliance with ethical and scientific standards. Approved researchers must sign a Data Use Agreement (DUA). Data will be provided in anonymized format for scientific and academic purposes only.

Locations

ID (1)