RecruitingACTRN12625000162415

Moringa Oleifera Supplementation for Reducing Heavy Metals Toxicity and Oxidative Stress in Pregnant Women

Sponsor

Directorate of Research, Technology, and Community Service of the Ministry of Education, Culture, Research, and Technology, Indonesia

Enrollment

80 participants

Start Date

Jul 11, 2024

Study Type

Interventional

Conditions

High of Oxidative Stress High Level of heavy metals in Pregnant women

Summary

This study protocol aims to evaluate the effectiveness of Moringa Oleifera supplementation in reducing heavy metal toxicity and oxidative stress biomarkers, 8-hydroxy-2'-deoxyguanosine (8-OHdG) and malondialdehyde (MDA), in pregnant women exposed to high levels of heavy metals. Methods: A quasi-experimental, non-randomized pre-post test design is used. Pregnant women with elevated heavy metal levels, identified through initial screening, will be included in the intervention group, receiving Moringa Oleifera supplementation for two months. The control group will consist of women from similar geographical regions who will not receive the intervention. Primary outcomes will include changes in heavy metal concentrations, measured using inductively coupled plasma mass spectrometry (ICP-MS). Secondary outcomes will focus on reductions in oxidative stress biomarkers, measured via enzyme-linked immunosorbent assay (ELISA). Statistical analyses, including ANCOVA, will be used to adjust for baseline differences between the groups. our hypothesis is that Supplementation of Moringa Leaves decreases heavy metals, MDA, and 8-OHdg level.

Eligibility

Sex: FemalesMin Age: 15 YearssMax Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

Heavy metals such as mercury, lead, and cadmium can accumulate in the body through environmental and dietary exposure. In pregnant women, elevated levels of these toxins can harm both the mother and the developing baby by causing oxidative stress — a form of cellular damage. Finding safe, accessible ways to reduce this exposure during pregnancy is critically important. This study is testing whether Moringa oleifera — a plant commonly used in traditional medicine and cooking in Southeast Asia — can reduce heavy metal levels and markers of cellular damage in pregnant women in Makassar, Indonesia. Pregnant women with elevated heavy metal levels will receive moringa leaf supplementation for two months, and their blood and urine will be tested before and after. You may be eligible if you are pregnant in your second or third trimester, plan to give birth in Makassar, have been living there for over a year, do not have a chronic illness, and have blood tests showing elevated mercury, lead, or cadmium levels. Single pregnancies only — those expecting twins are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The intervention group will receive moringa extract supplement (2000 mg/day) consisting of two capsules twice per day. The duration of the administration will be two months. We collaborate with the h

The intervention group will receive moringa extract supplement (2000 mg/day) consisting of two capsules twice per day. The duration of the administration will be two months. We collaborate with the health cadres at the health center. We ask them to supervise, remind, and ensure the mother take the capsules. We created a WhatsApp group for cadres to monitor and remind them to supervise the participants.. The cadres will remind the participant to administer the moringa through the whatsapp group and the participant report it the groups. Mode of administration is powder in capsule.. Researcher determine allocation based on the mother's level of heavy metals. We determine each of the intervention and control group is in the same health centres to ease the monitoring

Locations(1)

South Sulawesi, Indonesia

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ACTRN12625000162415