| CTRI Number |
CTRI/2025/05/087795 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Nutritional Profiling of Moringa Leaves and Its Impact on Growth and Micronutrient Status in Children Aged 6–24 Months |
|
Scientific Title of Study
|
Comprehensive studies on nutritional characterization of drumstick leaves (Moringa oleifera) and efficacy testing in young children (6-24 months age group) on growth and micronutrient status |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhari Srisailam Radhika |
| Designation |
Scientist F and HOD |
| Affiliation |
ICMR- National Institute of Nutrition |
| Address |
ICMR-National Institute of Nutrition, Jamai Osmania PO,
Hyderabad
radhika.madhari@gmail.com
Hyderabad
TELANGANA
500007
India |
| Phone |
9440401160 |
| Fax |
|
| Email |
radhika.ms@icmr.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhari Srisailam Radhika |
| Designation |
Scientist F and HOD |
| Affiliation |
ICMR- National Institute of Nutrition |
| Address |
ICMR-National Institute of Nutrition, Jamai Osmania PO,
Hyderabad
radhika.madhari@gmail.com
Hyderabad
TELANGANA
500007
India |
| Phone |
9440401160 |
| Fax |
|
| Email |
radhika.ms@icmr.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr P S Prasanthi |
| Designation |
Technical Officer A |
| Affiliation |
ICMR- National Institute of Nutrition |
| Address |
ICMR-National Institute of Nutrition, Jamai Osmania PO,
Hyderabad
Hyderabad
TELANGANA
500007
India |
| Phone |
9293715758 |
| Fax |
|
| Email |
psprasanthivenu@gmail.com |
|
|
Source of Monetary or Material Support
|
| ICMR- National Institute of Nutrition, Jamai Osmania, Tarnaka, Hyderabad, Telangana, India. 500007 |
|
|
Primary Sponsor
|
| Name |
ICMR- National Institute of Nutrition |
| Address |
ICMR-National Institute of Nutrition, Jamai Osmania PO, Hyderabad 500007, 040-27197421 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Madhari Srisailam Radhika |
ICMR- National Institute of Nutrition |
Department of Dietetics,
ICMR-National Institute of Nutrition,
Jamai Osmania PO,
Hyderabad 500007
Hyderabad
TELANGANA |
9440401160
radhika.ms@icmr.gov.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ICMR - NIN Institutional Ethical Committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
For intervention and acceptability study: Young children below 2 years and for sensory evaluation: Adults 20 to 39 years of age
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Existing Take Home Ration(THR) provided by ICDS for complementary feeding in the state of Telangana |
THR is prepared from more of cereal and refined sugar with little pulse, dairy and healthy fat (18 months) |
| Intervention |
Optimized nutrient dense Moringa based complementary food mixes |
Moringa based complementary food mixes will be optimized from locally available food stuffs to maximize nutrient content and minimize anti nutrient content and further acceptability and intervention trial will be carried out to evaluate its impact on growth, anemia and micro nutrient status (Vitamin A) for a period of 12 months (18 months) |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
24.00 Month(s) |
| Gender |
Both |
| Details |
Children:
All children in the age group of 6 to 24 months identified as beneficiaries of SNP-ICDS and their mothers/caregivers residing in urban slum within Hyderabad.
Consuming solid foods / THR for at least the past 30 days.
Apparently healthy, not presently suffering from acute illness. (fever, cough, cold, etc..,).
No known food allergies.
Children with moderate anemia, mild anemia and those with normal haemoglobin (Hb) status
Have weight for age, height for age and/or weight for height greater than or equal to -3 z score.
Have written informed consent from their parents, and
Planning to remain in the trial area and continue for the entire duration of the study
For adult sensory panel:
The members of the sensory panel who are in the age group of 20-39 years, having no current illness such as fever, gastrointestinal disturbances, food intolerance/allergies, no taste/odour perception disorders, no color blindness, no denture defects, no minor infections of nose and throat, and willing to participate during all the time points will be selected and included in the study.
|
|
| ExclusionCriteria |
| Details |
Children who :
have haemoglobin (lesser than 8 g per dL)
are severely undernourished (WAZ, HAZ and WHZ lesser than -3 z scores).
are not the beneficiaries of ICDS are excluded.
do not consume the existing THR the past 30 days.
are suffering from acute/chronic illness
have known allergy to milk products, wheat products, nuts etc.
refuse to participate in the trial
are participating in any other research trial
For adults,
all who do not satisfy the inclusion criteria
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Feasible nutrient dense semi-perishable food formulations with high protein quality, prepared from diverse local foods and drumstick leaves will be developed for complementary feeding, tested for organoleptic properties and acceptability among children, mothers and healthy adult participants and further intervention trial on its impact on growth, anemia and micro nutrient (Vitamin A) status will be tested among young children . |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To develop and standardize Moringa based recipes(incorporating moringa leaves in commonly consumed recipes) and estimating the contribution of the moringa based food mixes and the standardized recipes to the Estimated Average Requirements of macronutrients and micronutrients such as vitamin A, calcium and iron in different vulnerable age, gender and physiological groups. |
5 months |
| To assess the effect of food processing including different drying and cooking methods on retention and bioavailability of beta-carotene, calcium, iron and content of selected bio-active components in the optimized food mixes and standardized recipes. |
10 months |
| Final data management and reporting |
3 months |
|
|
Target Sample Size
|
Total Sample Size="306"
Sample Size from India="306"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [radhika.madhari@gmail.com].
- For how long will this data be available start date provided 01-09-2025 and end date provided 01-12-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
According to National Family Health Survey-5 the prevalence of underweight, wasting, stunting, and anemia among under 5 years children is reported to be high i.e., 32.1%, 19.3%, 35.5% and 67.1% respectively. Further the Comprehensive National Nutrition Survey CNNS study (2016-2018) also reported considerable prevalence of micronutrient deficiencies among 1-4 young children (32% of Iron deficiency, 19% of zinc deficiency, 18% of Vitamin A deficiency,) which poses a significant risk to undesirable health. There is a need to address these issues by implementing strategies to enhance healthy food and nutrient intakes through dietary interventions that include food to food fortification and supplementation strategies that can be crucial in reducing malnutrition, micronutrient deficiencies and improving overall child health and nutritional status. Incorporating nutrient-dense foods like Moringa oleifera into young child diets can contribute significantly in addressing these issues since it is a good source of calcium (Ca), protein and iron (Fe), and other bioactive compounds. It is worth exploring the potential of drumstick leaves fortified complementary food mix to improve growth and micronutrient status of young children. However, Moringa leaves are not popularly used in regular diets, and there are limited studies reported on the potential use of Moringa leaves in a food-to-food fortification perspective. Therefore, this study intends to optimize blended complementary food mix incorporating moringa leaf powder, test its acceptability and effect on growth, anemia and micronutrient status among 6–24-month-old children. The composition of nutrients and bio-actives present in moringa leaves, the effect of domestic processing on nutrient retention and bio-availability of selected micro nutrients will also be studied. |