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Moringa Oleifera (Drumstick Leaves) for Improving Haemoglobin, Vitamin A Status and Underweight Among Adolescent Girls in Rural Bangladesh: A Quasi-experimental Study (Moringa)

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ClinicalTrials.gov Identifier: NCT04156321
Recruitment Status : Unknown
Verified October 2019 by International Centre for Diarrhoeal Disease Research, Bangladesh.
Recruitment status was:  Enrolling by invitation
First Posted : November 7, 2019
Last Update Posted : November 7, 2019
Sponsor:
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief 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 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. Outcome measures/variables:

Primary outcomes: Changes in 2 biochemical markers (haemoglobin and vitamin A).


Condition or disease Intervention/treatment Phase
Assess the Impact of Moringa Leaves on Serum Heamoglobin and Vitamin A Level Among the Adolescent Girls Dietary Supplement: Moringa fry Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 226 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Moringa Oleifera (Drumstick Leaves) for Improving Haemoglobin, Vitamin A Status and Underweight Among Adolescent Girls in Rural Bangladesh: A Quasi-experimental Study
Actual Study Start Date : September 1, 2019
Estimated Primary Completion Date : July 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin A

Arm Intervention/treatment
Experimental: Intervention
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
Dietary Supplement: Moringa fry

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 .


No Intervention: Control arm
Group II (Control) will rice, concenstrated dal and potato vaji. Both groups will receive calorie matched meal (411 kcal)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Changes in nutritional status [ Time Frame: At baseline, 3 months and 6 months of intervention ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 14 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-Unmarried adolescent girls aged 12-14 years will be enrolled from the selected high schools in our study,

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04156321


Locations
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Bangladesh
Icddr,B
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
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Principal Investigator: Mansura Khanam, Msc Research Investigator,NCSD, icddr,b
Additional Information:
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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT04156321    
Other Study ID Numbers: PR-19060
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: icddr,b has own data sharing policy. We will follow icddr,b data sharing policy.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Moringa, quasi-experimental, vitamin A, haemoglobin
Additional relevant MeSH terms:
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Thinness
Body Weight