Assess the Impact of Moringa Leaves on Serum Heamoglobin and Vitamin A Level Among the Adolescent Girls Clinical Trial
— MoringaOfficial title:
Moringa Oleifera (Drumstick Leaves) for Improving Haemoglobin, Vitamin A Status and Underweight Among Adolescent Girls in Rural Bangladesh: A Quasi-experimental Study
| Verified date | October 2019 |
| Source | International Centre for Diarrhoeal Disease Research, Bangladesh |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Enrolling by invitation |
| Enrollment | 226 |
| Est. completion date | September 30, 2020 |
| Est. primary completion date | July 30, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 12 Years to 14 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Bangladesh | Icddr,B | Dhaka |
| Lead Sponsor | Collaborator |
|---|---|
| International Centre for Diarrhoeal Disease Research, Bangladesh |
Bangladesh,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 -70°C 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. | At baseline, 3 months and 6 months of intervention | |
| Secondary | 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. | At baseline, 3 months and 6 months of intervention |