Assess the Impact of Moringa Leaves on Serum Heamoglobin and Vitamin A Level Among the Adolescent GirlsPhase 3MoringaNCT04156321
Moringa Oleifera (Drumstick Leaves) for Improving Haemoglobin, Vitamin A Status and Underweight Among Adolescent Girls in Rural Bangladesh: A Quasi-experimental Study
A Phase 3 study testing Moringa fry in people with Assess the Impact of Moringa Leaves on Serum Heamoglobin and Vitamin A Level Among the Adolescent Girls, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
Background (brief): 1. Burden: Bangladesh has a population of 29.5 million adolescents, which represents nearly one-fifth of the country's total population. Adequate nutrition during this critical age period is key, and is associated with improved health and development of the future adult population, as well as that… Read more about this study
- Who is it for?
- Ages 12 to 14 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Assess the Impact of Moringa Leaves on Serum Heamoglobin and Vitamin A Level Among the Adolescent Girls
- What is being tested?
- Moringa fry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Sep 2019to 30 Sep 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 14 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- -Unmarried adolescent girls aged 12-14 years will be enrolled from the selected high schools in our study,
Who cannot join
- Participants will be excluded if they are taking other nutritional supplements (vitamins and minerals) as this might affect the level of hemoglobin and other micronutrients that we intend to measure.
- Also adolescent girls with documented medical records of chronic diseases will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Background (brief):
- Burden: Bangladesh has a population of 29.5 million adolescents, which represents nearly one-fifth of the country's total population. Adequate nutrition during this critical age period is key, and is associated with improved health and development of the future adult population, as well as that of their future off-spring bringing potential inter-generational benefits. Yet, adolescents are known to face multiple nutritional challenges related to persistent undernutrition and micronutrient deficiencies as well as rapidly rising overweight and obesity due to inadequate and inappropriate nutritional practice. A large percentage of adolescents in Bangladesh consume an inadequate diet in terms of energy content, nutrient density and diversity. To alleviate micronutrient deficiency, Moringa oleifera leaves can be used in their daily diet with a traditional manner. It contains substantial amount of protein \& several essential micronutrients for growth.
- Knowledge gap: Although, adolescence has been identified as a 'second window of opportunity" for correcting nutritional inadequacies and insufficient growth from childhood, however, they face multiple nutritional challenges related to persistent undernutrition and micronutrient deficiencies, particularly in resource poor countries like Bangladesh.
- Relevance: About 80% of kilocalories per capita per day in Bangladesh are from micronutrient-poor foods, and 70% are from rice alone (75% for rural adolescents). A study on pregnant adolescent women showed that around 60% had low or medium dietary diversity. Among the major food groups, the routine diet of a Bangladeshi adolescent particularly lacks in protein in terms of both animal source like eggs, dairy products and plant source like legumes and nuts. Daily consumption of vitamin A-rich vegetables and fruits (other than dark-green leafy vegetables) are also inadequate. Such inadequate diet is reflected by various health outcomes. The prevalence of low Body Mass Index is 31% among married-adolescents of 15-19 years old. 13% of the adolescents are short in stature. Moringa leaves have a high amount of protein, and vitamins A \& C, calcium, iron, potassium and zinc. It is well-known and easily cultivable in Bangladesh with limited resource. The high nutrient content of the leaves make it suitable to bring transformative changes in diet and feeding practices within the purchasing capacity of marginalized people due to its availability and affordability. Our proposed approach will assess the impact of locally available, affordable and culturally accepted Moringa leaves consumption into adolescent's regular diet to improve their nutritional status as a whole.
- Hypothesis (if any): 150 gm of Sajna shak /bora (Moringa) 5 days/week) will improve haemoglobin and vitamin A status of the adolescent girls after 6 months of consumption.
- Objectives: The study objectives are as below: 1.1 Primary: To assess the effect of consumption of Sajna shak/bora (Moringa) on haemoglobin and vitamin A status among the adolescent girls after 6 months of consumption 1.2 Secondary: Assess the effect of Sajna shak/bora (Moringa) on adolescent weight gain after 6 months of consumption
- Methods: This will be a school-based trial. Group I (intervention) will receive 150 gm of Sajna shak/bora (Moringa) added with 25 gm concenstrated dal with 100 gm of rice as mid-morning snack in selected school 5 times a week for 6 months along with nutrition education. Group II (Control) will rice, concenstrated dal and potato vaji. Both groups will recieve calorie matched meal (411 kcal). Baseline and endline survey will be conducted. Blood sample will be collected at the baseline, at end of 3 months and at the endline. Compliance will be measured through on-spot feeding. Data on feeding, morbidity and anthropometry (height and weight) will be collected bi-monthly.
- Outcome measures/variables:
Primary outcomes: Changes in 2 biochemical markers (haemoglobin and vitamin A).
- Being tested
- Moringa fry
- Keywords
- Moringa, quasi-experimental, vitamin A, haemoglobin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moringa fryDietary supplement
School Tiffin:
Each of the adolescent girls will receive fresh Moringa leaves (150 gram) cooked in a traditional manner as Sajna shak (stir-fried)/ bora with rice and concentrated dal once daily for 5 days during tiffin time. Sajna Stir fry and bora will be given on every alternative day. Standard questionnaire will be used to measure the compliance of food. As we are serving the food in school premises during tiffin period, it would be both unethical and socially unacceptable if few of the students from a section receive the meal. Therefore, all the students from selected section/sections will receive the daily meal. However, we will only collect information from the selected study participants who would give consent to participate in the study Each of the combination of tiffin meal will supply 411 calories in the both arm .
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Group I (intervention) will receive 150 gm of Sajna shak/bora (Moringa) added with 25 gm concenstrated dal with 100 gm of rice as mid-morning snack in selected school 5 times a week for 6 months Receives: Dietary Supplement: Moringa fry |
| Control arm | No intervention | Group II (Control) will rice, concenstrated dal and potato vaji. Both groups will receive calorie matched meal (411 kcal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in 2 biochemical markers (serum haemoglobin and retinol level)
Peripheral blood samples will be collected from all participants from both intervention and control groups. Blood samples collected will be labelled with a bar-coded identification label specifically created for this study, and corresponding to study subject identification number. In this way, the laboratory could easily identify, which particular clusters are to be tested in a batch and thus minimizing the possibilities of increasing freeze/thaw cycles. A sample record/hBandover form will be filled up indicating name of the participants, ID number, sample ID number, and type of analysis to be done. The samples will be carried to the nutritional biochemistry laboratory in Dhaka in temperature controlled cooler box. Samples will be received at the laboratory and stored in a -70⁰C freezer and analyzed to estimate the blood parameters. Mean hemoglobin level (gm/dl) and serum level of retinol (mmol/l) will be measured at baseline ,3 months and after 6 months of intervention.
Measured: At baseline, 3 months and 6 months of intervention
Secondary outcomes (1)
Changes in nutritional status
Trained staff will collect anthropometric measurements (weight in kg and height in cm) monthly using established methods. Measurement would be taken at baseline, every 2 months thereafter for 6 months. Weight will be measured with minimal clothing and without any shoes and accessories in kilograms using portable Tania scale with an accuracy of accuracy of 100 g. Height will be measured at cm with height meter with 1 mm accuracy. The entire instrument will be calibrated every morning with a standard weight and height board accordingly, prior to data collection. These measurements will be standardized before and during the data collection. For our analysis of BMI status, all BMI data will be converted and categorized according to WHO cutoff points. Using the WHO BMI-for-age growth chart for girls ages 5 to 19 years, normal weight, overweight (>+1 SD, equivalent to BMI 25 kg/m obese (>+2 SD, equivalent to BMI 30 kg/m2 each study.
Measured: At baseline, 3 months and 6 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start1 Sep 2019
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assess the Impact of Moringa Leaves on Serum Heamoglobin and Vitamin A Level Among the Adolescent GirlsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mansura Khanam, Msc, Principal investigator, Research Investigator,NCSD, icddr,b
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04156321
- Sponsor's protocol ID
- PR-19060
- Acronym
- Moringa
- Status last verified
- Oct 2019
- First submitted
- 17 Oct 2019
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: icddr,b has own data sharing policy. We will follow icddr,b data sharing policy.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moringa Oleifera (Drumstick Leaves) for Improving Haemoglobin, Vitamin A Status and Underweight Among Adolescent Girls in Rural Bangladesh: A Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT04156321
- Acronym / sponsor ID
- Moringa / PR-19060
- Keywords
- Moringa, quasi-experimental, vitamin A, haemoglobin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 226 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 7 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background (brief):
- Burden: Bangladesh has a population of 29.5 million adolescents, which represents nearly one-fifth of the country's total population. Adequate nutrition during this critical age period is key, and is associated with improved health and development of the future adult population, as well as that of their future off-spring bringing potential inter-generational benefits. Yet, adolescents are known to face multiple nutritional challenges related to persistent undernutrition and micronutrient deficiencies as well as rapidly rising overweight and obesity due to inadequate and inappropriate nutritional practice. A large percentage of adolescents in Bangladesh consume an inadequate diet in terms of energy content, nutrient density and diversity. To alleviate micronutrient deficiency, Moringa oleifera leaves can be used in their daily diet with a traditional manner. It contains substantial amount of protein \& several essential micronutrients for growth.
- Knowledge gap: Although, adolescence has been identified as a 'second window of opportunity" for correcting nutritional inadequacies and insufficient growth from childhood, however, they face multiple nutritional challenges related to persistent undernutrition and micronutrient deficiencies, particularly in resource poor countries like Bangladesh.
- Relevance: About 80% of kilocalories per capita per day in Bangladesh are from micronutrient-poor foods, and 70% are from rice alone (75% for rural adolescents). A study on pregnant adolescent women showed that around 60% had low or medium dietary diversity. Among the major food groups, the routine diet of a Bangladeshi adolescent particularly lacks in protein in terms of both animal source like eggs, dairy products and plant source like legumes and nuts. Daily consumption of vitamin A-rich vegetables and fruits (other than dark-green leafy vegetables) are also inadequate. Such inadequate diet is reflected by various health outcomes. The prevalence of low Body Mass Index is 31% among married-adolescents of 15-19 years old. 13% of the adolescents are short in stature. Moringa leaves have a high amount of protein, and vitamins A \& C, calcium, iron, potassium and zinc. It is well-known and easily cultivable in Bangladesh with limited resource. The high nutrient content of the leaves make it suitable to bring transformative changes in diet and feeding practices within the purchasing capacity of marginalized people due to its availability and affordability. Our proposed approach will assess the impact of locally available, affordable and culturally accepted Moringa leaves consumption into adolescent's regular diet to improve their nutritional status as a whole.
- Hypothesis (if any): 150 gm of Sajna shak /bora (Moringa) 5 days/week) will improve haemoglobin and vitamin A status of the adolescent girls after 6 months of consumption.
- Objectives: The study objectives are as below: 1.1 Primary: To assess the effect of consumption of Sajna shak/bora (Moringa) on haemoglobin and vitamin A status among the adolescent girls after 6 months of consumption 1.2 Secondary: Assess the effect of Sajna shak/bora (Moringa) on adolescent weight gain after 6 months of consumption
- Methods: This will be a school-based trial. Group I (intervention) will receive 150 gm of Sajna shak/bora (Moringa) added with 25 gm concenstrated dal with 100 gm of rice as mid-morning snack in selected school 5 times a week for 6 months along with nutrition education. Group II (Control) will rice, concenstrated dal and potato vaji. Both groups will recieve calorie matched meal (411 kcal). Baseline and endline survey will be conducted. Blood sample will be collected at the baseline, at end of 3 months and at the endline. Compliance will be measured through on-spot feeding. Data on feeding, morbidity and anthropometry (height and weight) will be collected bi-monthly.
- Outcome measures/variables:
Primary outcomes: Changes in 2 biochemical markers (haemoglobin and vitamin A).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Moringa fryGroup I (intervention) will receive 150 gm of Sajna shak/bora (Moringa) added with 25 gm concenstrated dal with 100 gm of rice as mid-morning snack in selected school 5 times a week for 6 months |
| Control arm | No intervention | –Group II (Control) will rice, concenstrated dal and potato vaji. Both groups will receive calorie matched meal (411 kcal) |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- -Unmarried adolescent girls aged 12-14 years will be enrolled from the selected high schools in our study,
Key exclusion criteria (2 listed)
- Participants will be excluded if they are taking other nutritional supplements (vitamins and minerals) as this might affect the level of hemoglobin and other micronutrients that we intend to measure.
- Also adolescent girls with documented medical records of chronic diseases will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moringa frySchool Tiffin: Each of the adolescent girls will receive fresh Moringa leaves (150 gram) cooked in a traditional manner as Sajna shak (stir-fried)/ bora with rice and concentrated dal once daily for 5 days during tiffin time. Sajna Stir fry and bora will be given on every alternative day. Standard questionnaire will be used to measure the compliance of food. As we are serving the food in school premises during tiffin period, it would be both unethical and socially unacceptable if few of the students from a section receive the meal. Therefore, all the students from selected section/sections will receive the daily meal. However, we will only collect information from the selected study participants who would give consent to participate in the study Each of the combination of tiffin meal will supply 411 calories in the both arm . | Dietary supplement | Intervention |
Primary outcome
Changes in 2 biochemical markers (serum haemoglobin and retinol level)
Time frame: At baseline, 3 months and 6 months of intervention
Peripheral blood samples will be collected from all participants from both intervention and control groups. Blood samples collected will be labelled with a bar-coded identification label specifically created for this study, and corresponding to study subject identification number. In this way, the laboratory could easily identify, which particular clusters are to be tested in a batch and thus minimizing the possibilities of increasing freeze/thaw cycles. A sample record/hBandover form will be filled up indicating name of the participants, ID number, sample ID number, and type of analysis to be done. The samples will be carried to the nutritional biochemistry laboratory in Dhaka in temperature controlled cooler box. Samples will be received at the laboratory and stored in a -70⁰C freezer and analyzed to estimate the blood parameters. Mean hemoglobin level (gm/dl) and serum level of retinol (mmol/l) will be measured at baseline ,3 months and after 6 months of intervention.
1 secondary outcome
Changes in nutritional status
Time frame: At baseline, 3 months and 6 months of intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. icddr,b has own data sharing policy. We will follow icddr,b data sharing policy.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mansura Khanam, Msc principal investigator
Research Investigator,NCSD, icddr,b
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Moringa fry in people with Assess the Impact of Moringa Leaves on Serum Heamoglobin and Vitamin A Level Among the Adolescent Girls, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in 2 biochemical markers (serum haemoglobin and retinol level) (time frame: At baseline, 3 months and 6 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2019.