None listed
Conditions
Brief 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.
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 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
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
Sponsors
Directorate of Research, Technology, and Community Service of the Ministry of Education, Culture, Research, and Technology, Indonesia
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
15 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Pregnancy during the second or third trimester 2. Intention to deliver in Makassar 3. Not enduring twin pregnancy 4. Absence of chronic diseases 5. Living in Makassar for a period exceeding one year 6. Blood levels of mercury, lead, or cadmium exceed the reference value
Exclusion criteria
1. pregnant with the condition that is impossible to take blood 2. Not available for involvement
Outcome results
None listed