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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Hemoglobin Levels
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 44 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Intervention Group - Moringa Oleifera Leaf Micronized Powders + Standard Iron Tablets
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.
干预措施: Moringa Oleifera Leaf Micronized Powders in Capsule (Dietary Supplement)
Intervention Group - Moringa Oleifera Leaf Micronized Powders + Standard Iron Tablets
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.
干预措施: Standard Iron Tablets (Fe + Folic Acid) (Drug)
Active Comparator: Control Group - Standard Iron Tablets Only
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).
干预措施: Standard Iron Tablets (Fe + Folic Acid) (Drug)
结局指标
主要结局
Hemoglobin Levels
时间窗: 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.
次要结局
- 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)
- Serum Glutamate Pyruvate Transaminase (SGPT)(Baseline (Day 0) and Day 60)
- Serum Glutamate Oxaloacetate Transaminase (SGOT)(Baseline (Day 0) and Day 60)
- Serum Creatinine Levels(Baseline (Day 0) and Day 60)
- Peripheral Blood Smear Analysis(Baseline (Day 0) and Day 60)
- Hematocrit Levels(Baseline (Day 0) and Day 60)
- Mean Corpuscular Volume (MCV)(Baseline (Day 0) and Day 60)
- Mean Corpuscular Hemoglobin (MCH)(Baseline (Day 0) and Day 60)
- Mean Corpuscular Hemoglobin Concentration (MCHC)(Baseline (Day 0) and Day 60)
- Serum Iron(Baseline (Day 0) and Day 60)
- Serum Hepcidin Levels(Baseline (Day 0) and Day 60)
- Serum IL-6 Levels(Baseline (Day 0) and Day 60)
研究者
H. Awie Darwizar, M.D., Sp.OG., D.MAS., MMRS., FIHFAA
Principal Investigator, Department of Obstetrics and Gynecology
Fakultas Kedokteran Universitas Padjadjaran