Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001661268
Ethics application status
Approved
Date submitted
29/09/2018
Date registered
9/10/2018
Date last updated
12/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of Moringa oleifera leaf powder supplementation in pregnant mothers on maternal and birth outcomes.
Scientific title
Effects of Moringa oleifera leaf powder supplementation in pregnant mothers on maternal health and birth weight in Jeneponto District, South Sulawesi Indonesia.
Secondary ID [1] 296212 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Pregnant mothers with anemia in the early third trimester. 309846 0
Condition category
Condition code
Alternative and Complementary Medicine 308635 308635 0 0
Herbal remedies
Diet and Nutrition 308636 308636 0 0
Other diet and nutrition disorders
Reproductive Health and Childbirth 308637 308637 0 0
Antenatal care
Blood 308664 308664 0 0
Anaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is an intervention study about providing Moringa oleifera (MO) leaf powder capsules to the pregnant mothers. Study location was in Tamalatea sub-district, Jeneponto districts, South Sulawesi. It takes three hours by car from Makassar city, the capital city of South Sulawesi, to the study location. The subjects were pregnant mothers in the early third semester. First, pregnant mothers were measured for hemoglobin level by trained field workers. Then, mothers with anemia were taken into the study. Anemia was defined using WHO category which is less than 11mg/dl. For ethical reason, we took only those who had haemoglobin level between 10-11mg/dl. Measurements were performed before and after treatment for anthropometric, food intakes, stress status, and cortisol concentration in blood. Mothers were randomly divided into two groups based on order on enrolment; group received two capsules (each 500mg) of MO twice a days (MG, n=19) and group received two similar capsule (contained 60mg iron/30ug folic acid) (IG, n=19). The groups were categorized A and B but it was blinded to the field investigators which group contained MO or Iron/folic acid. Intervention was done for eight weeks. The field workers distributed the capsule every week and asking the empty bottle prior to giving the next bottle. Mothers were controlled for their capsule consumption by sending short massages or called by the field workers. The short message was sent first in the morning and second in the afternoon. The content of the short message was to remind mothers to take the capsule and they have to reply that they had taken it. The sentence in the morning was "Have you consumed the capsule this morning?" while the sentence in the afternoon was "Have you consumed the capsule this afternoon?" Most of the mothers replied directly to the short message at the same day (both morning and afternoon). When there were no reply of the short message from the mothers, the field workers gave a call. In general, the call was done only once at the afternoon. At birth, mothers were weight together with their babies.
Intervention code [1] 312539 0
Treatment: Other
Comparator / control treatment
Subjects in control group received capsules with similar colour and amount contained 60mg of elemental Iron and 400mcg of folic acid. It was distributed in similar manner with those in the intervention group.
Control group
Active

Outcomes
Primary outcome [1] 307595 0
Hemoglobin level. It is measured using cyanmethemoglobin method through Diaspect (Germany). A little whole blood from finger tip was taken by the field workers by a disposible tool and it was entered into the Diaspect (the device for measurement), In around one or two minutes, the result could be read at the screen.
Timepoint [1] 307595 0
Before and After 8 weeks of intervention commencement
Primary outcome [2] 307596 0
Maternal Stress using standard questionnaire. called Depression Anxiety Stress Scale (DASS 42)
Timepoint [2] 307596 0
Before and After 8 weeks of intervention commencement or the first time mothers consumed the capsule.
Primary outcome [3] 307597 0
Cortisol concentration measured using saliva with ELISA Method.
Timepoint [3] 307597 0
Before and after 8 weeks of intervention.commencement or the first time mothers consumed the capsule.
Secondary outcome [1] 352381 0
Birth Weight, using a standard baby weighing scale.
Timepoint [1] 352381 0
At the time of baby born.
Secondary outcome [2] 352446 0
Weight of mothers was measure by a standardized weighing scale.
Timepoint [2] 352446 0
Before and after 8 weeks of intervention commencement (the first time mother consumed the capsule)
Secondary outcome [3] 352447 0
Food intakes was assessed by 24-hours recall.
Timepoint [3] 352447 0
Before and 8 weeks after the intervention commencement (the first time mothers consumed the capsule)
Secondary outcome [4] 352449 0
Side effects of treatment were measured by a standardized form.. The form was designed specifically for this study. The field workers asked to the mothers whether there are any problems after consuming the capsule.
Timepoint [4] 352449 0
Every week after intervention commencement.

Eligibility
Key inclusion criteria
- Hemoglobin between 10 to 11gr/dl
- Age of pregnancy is equal or above 28 weeks
- Parity is equal or less than three
- Willing to participate into the study
Minimum age
17 Years
Maximum age
41 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Mothers who consumed other supplements.
Mothers with pregnancy complications such as hypertension, diabetes, others)
Mothers with bleeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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)
We used group A and B. The mother was allocated to group A if she took a small paper with letter A and to group B if she took a small paper with letter B. There were only 20 small paper with letter A and 20 with letter B.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation was based on previous study looking at the effect Moringa supplementation to pregnant mothers with anaemia on birth weight. The result showed 16. Considering for drop-out, amount of subjects in this study was 20. We used t-test both paired and independent. Different between before and after intervention in each group was used paired t-test while the different of change between groups was used independent t-test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/01/2018
Date of last participant enrolment
Anticipated
Actual
26/03/2018
Date of last data collection
Anticipated
Actual
30/07/2018
Sample size
Target
20
Accrual to date
Final
19
Recruitment outside Australia
Country [1] 20879 0
Indonesia
State/province [1] 20879 0
South Sulawesi

Funding & Sponsors
Funding source category [1] 300798 0
University
Name [1] 300798 0
Hasanuddin University
Country [1] 300798 0
Indonesia
Primary sponsor type
Individual
Name
Prof. Veni Hadju
Address
School of Post Graduate
Hasanuddin University
Jl. Perintis Kemerdekaan, km. 10
Makassar, South Sulawesi, Indonesia
Country
Indonesia
Secondary sponsor category [1] 300353 0
None
Name [1] 300353 0
Address [1] 300353 0
Country [1] 300353 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301580 0
Hasanuddin University
Ethics committee address [1] 301580 0
Faculty of Medicine
Hasanuddin University
Jl. Perintis Kemerdekaan, km.10
Makassar, South Sulawesi
Ethics committee country [1] 301580 0
Indonesia
Date submitted for ethics approval [1] 301580 0
01/11/2017
Approval date [1] 301580 0
28/12/2017
Ethics approval number [1] 301580 0

Summary
Brief summary
The purpose of the study was to assess the effect of Moringa oleifera (MO) leaf powder supplementation in pregnant mothers on maternal health and birth weight. We hypothesized that anaemic pregnant mothers who received two grams of MO capsuled are better in haemoglobin level, stress, cortisol level, and birth weight compared to mothers who received a conventional iron folic acid intervention. Pregnant mothers were randomly divided into two groups, group received MO two capsules twice daily and group received iron folate with similar colour capsules for eight weeks. Measurements were performed by trained field workers before and after intervention for anthropometric, haemoglobin level, maternal stress, and cortisol level. Weight of the baby was measured at birth.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3133 3133 0 0
/AnzctrAttachments/376099-ethial approval .pdf (Ethics approval)

Contacts
Principal investigator
Name 87454 0
Prof Veni Hadju
Address 87454 0
School of Public Health
Hasanuddin University
Jl. Perintis Kemerdekaan, km.10
Makassar, Indonesia
Country 87454 0
Indonesia
Phone 87454 0
62411585658
Fax 87454 0
62411586013
Email 87454 0
phunhas@gmail.com
Contact person for public queries
Name 87455 0
Prof Veni Hadju
Address 87455 0
School of Public Health
Hasanuddin University
Jl. Perintis Kemerdekaan, km.10
Makassar, Indonesia
Country 87455 0
Indonesia
Phone 87455 0
62411585658
Fax 87455 0
62411586013
Email 87455 0
phunhas@gmail.com
Contact person for scientific queries
Name 87456 0
Prof Veni Hadju
Address 87456 0
School of Public Health
Hasanuddin University
Jl. Perintis Kemerdekaan, km.10
Makassar, Indonesia
Country 87456 0
Indonesia
Phone 87456 0
62411585658
Fax 87456 0
62411586013
Email 87456 0
phunhas@gmail.com

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