Clinical trial NCT04156321: Moringa Oleifera (Drumstick Leaves) for Improving Haemoglobin, Vitamin A Status and Underweight Among Adolescent Girls in Rural Bangladesh: A Quasi-experimental Study
Official title: Moringa Oleifera (Drumstick Leaves) for Improving Haemoglobin, Vitamin A Status and Underweight Among Adolescent Girls in Rural Bangladesh: A Quasi-experimental Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Assess the Impact of Moringa Leaves on Serum Heamoglobin and Vitamin A Level Among the Adolescent Girls
Keywords: Moringa, quasi-experimental, vitamin A, haemoglobin
Lead sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh
Sponsor class: OTHER
First posted: 2019-11-07
Enrollment: 226
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility 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.

Primary outcomes:
measure: Changes in 2 biochemical markers (serum haemoglobin and retinol level)
timeFrame: At baseline, 3 months and 6 months of intervention
Secondary outcomes:
measure: Changes in nutritional status
timeFrame: At baseline, 3 months and 6 months of intervention
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Icddr,B
Study officials:
affiliation: Research Investigator,NCSD, icddr,b
name: Mansura Khanam, Msc
role: PRINCIPAL_INVESTIGATOR
References: