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Trial registered on ANZCTR


Registration number
ACTRN12625000162415
Ethics application status
Approved
Date submitted
2/12/2024
Date registered
12/02/2025
Date last updated
12/02/2025
Date data sharing statement initially provided
12/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Moringa Oleifera Supplementation for Reducing Heavy Metals Toxicity and Oxidative Stress in Pregnant Women
Scientific title
Moringa Oleifera Supplementation for Reducing Heavy Metals Toxicity and Oxidative Stress in Pregnant Women
Secondary ID [1] 313508 0
none
Universal Trial Number (UTN)
U1111-1313-5572
Trial acronym
MOTHM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High Level of heavy metals in Pregnant women 335936 0
High of Oxidative Stress 335937 0
Condition category
Condition code
Alternative and Complementary Medicine 332523 332523 0 0
Other alternative and complementary medicine
Alternative and Complementary Medicine 332704 332704 0 0
Herbal remedies
Injuries and Accidents 332705 332705 0 0
Poisoning
Alternative and Complementary Medicine 332706 332706 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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
Intervention code [1] 330079 0
Treatment: Other
Comparator / control treatment
Control group
Mothers in the control group will receive iron supplement. The supplement is a standard supplement provided by Health Centers as part of their routine program.
Control group
Active

Outcomes
Primary outcome [1] 340042 0
heavy metals level
Timepoint [1] 340042 0
before and after 2 months after administration of moringa suplement
Primary outcome [2] 340236 0
8-OHdG level
Timepoint [2] 340236 0
base line and two months after administration
Secondary outcome [1] 442468 0
Malondialdehyde (MDA) level
Timepoint [1] 442468 0
baseline and 2 months after administration of moringa suplement

Eligibility
Key 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
Minimum age
15 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. pregnant with the condition that is impossible to take blood
2. Not available for involvement

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using sample determination with experiment formuhla, we got a sample size of 4o people for each group. Analysis of group differences (pre-and post-intervention). For each group, analysis will be conducted using the paired t-test or Wilcoxon signed-rank test, depending on data distribution, to assess changes in heavy metals, MDA, and 8-OHdG levels before and after intervention.
Comparison between the groups (intervention vs. control). Analysis will be conducted using the difference-in-differences (DiD) method to measure the difference in changes between the intervention and control groups. The results will provide an overview of the impact of moringa leaf supplementation on the reduction of heavy metals level and prevention of DNA damage in pregnant women. To minimize bias, confounding factor such as nutritional status, environmental exposure, and diet will be analyzed using Analysis of Covariance (ANCOVA)

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/07/2024
Date of last participant enrolment
Anticipated
21/02/2025
Actual
Date of last data collection
Anticipated
24/03/2025
Actual
Sample size
Target
80
Accrual to date
40
Final
Recruitment outside Australia
Country [1] 26768 0
Indonesia
State/province [1] 26768 0
South Sulawesi

Funding & Sponsors
Funding source category [1] 317959 0
Government body
Name [1] 317959 0
Directorate of Research, Technology, and Community Service of the Ministry of Education, Culture, Research, and Technology, Indonesia
Country [1] 317959 0
Indonesia
Primary sponsor type
Government body
Name
Directorate of Research, Technology, and Community Service of the Ministry of Education, Culture, Research, and Technology, Indonesia
Address
Country
Indonesia
Secondary sponsor category [1] 320295 0
None
Name [1] 320295 0
Address [1] 320295 0
Country [1] 320295 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316631 0
Ethics Committee of the Public Health Faculty Hasanuddin University
Ethics committee address [1] 316631 0
Faculty of Public Health. Hasanuddin University. Jl. Perintis Kemerdekaan KM. 10 Tamalanrea. Makassar. Indonesia.
Ethics committee country [1] 316631 0
Indonesia
Date submitted for ethics approval [1] 316631 0
24/06/2024
Approval date [1] 316631 0
02/07/2024
Ethics approval number [1] 316631 0
1549/UN4.14.1/TP.01.02/2024

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138470 0
Dr Hasnawati Amqam
Address 138470 0
Facultu of Public Health. Hasanuddin University. Tamalanrea. Makassar City. Indonesia. 90245
Country 138470 0
Indonesia
Phone 138470 0
+628114630476
Fax 138470 0
Email 138470 0
[email protected]
Contact person for public queries
Name 138471 0
Hasnawati Amqam
Address 138471 0
Facultu of Public Health. Hasanuddin University. Tamalanrea. Makassar City. Indonesia. 90245
Country 138471 0
Indonesia
Phone 138471 0
+628114630476
Fax 138471 0
Email 138471 0
[email protected]
Contact person for scientific queries
Name 138472 0
Hasnawati Amqam
Address 138472 0
Facultu of Public Health. Hasanuddin University. Tamalanrea. Makassar City. Indonesia. 90245
Country 138472 0
Indonesia
Phone 138472 0
+628114630476
Fax 138472 0
Email 138472 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.