Undernutrition, Anemia, Stunting, Cognitive Function 1, Social
Conditions
Keywords
Nutrition
Brief summary
The goal of this clinical trial is to learn whether a locally developed supplement called MRJ - a combination of Moringa oleifera (drumstick tree) extract and royal jelly - can improve the nutritional status and cognitive function of adolescent girls more effectively than standard iron and folic acid (IFA) tablets. The main questions it aims to answer are: Does MRJ supplementation lead to better improvements in nutrition (e.g., hemoglobin, body measurements)? Does MRJ supplementation enhance cognitive function compared to IFA tablets? Researchers will compare MRJ capsules to IFA tablets (the standard of care) among adolescent girls. Participants will: Take 2 MRJ capsules per week (intervention group) or 1 IFA tablet per week (control group) for 12 months Receive nutrition education via short TikTok-based videos Have their adherence monitored weekly by teachers and through WhatsApp photos Measurements will be taken at the start, 6 months, and 12 months, including: Height, weight, and mid-upper arm circumference (MUAC) Hemoglobin levels via finger-prick blood test Dietary intake using a 24-hour recall and food frequency questionnaire (FFQ) Cognitive function assessed with the Culture Fair Intelligence Test (CFIT) Participants are healthy junior and senior high school girls aged 10-18 years from Galesong Selatan, Takalar District, South Sulawesi, Indonesia. Potential side effects (e.g., nausea or stomach discomfort) will be monitored according to school health protocols. The findings may support the use of culturally appropriate, nutrient-rich interventions for improving adolescent girls' health and future well-being.
Detailed description
This clinical trial aims to evaluate whether a locally produced supplement, MRJ (a combination of Moringa oleifera extract and royal jelly), can improve nutritional status and cognitive function among adolescent girls in South Sulawesi, Indonesia, compared to the standard iron and folic acid (IFA) tablets provided by the government. If proven effective, MRJ may serve as a culturally acceptable and nutrient-rich alternative to support adolescent health and development.
Interventions
DIETARY_SUPPLEMENTMoringa Oleifera
Participants receive MRJ capsules containing 490 mg of Moringa oleifera leaf extract and 10 mg of royal jelly, taken orally twice per week for 12 months. The capsules are plant-based, produced using locally sourced ingredients, and are part of a food-based supplementation strategy developed as an alternative to iron-folic acid tablets. The intervention is combined with standardized nutrition education via TikTok videos. Adherence is monitored weekly through teacher log sheets and WhatsApp documentation. and Participants receive iron-folic acid (IFA) tablets containing 60 mg of elemental iron and 400 µg of folic acid, taken orally once per week for 12 months in accordance with Indonesia's national supplementation guidelines for adolescent girls. This control intervention is combined with the same standardized nutrition education via TikTok videos. Compliance is tracked weekly through teacher-supervised control sheets and WhatsApp photo submissions.
Sponsors
Hasanuddin University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 19 Years
Healthy volunteers
Yes
Inclusion criteria
* (1) Age 10-19 years (2) Adolescent girls' who are active in grades 1 and 2 (junior high and senior high)
Exclusion criteria
* (3) Severe nutritional or health conditions (e.g., severe anemia, severe malnutrition, allergies), determined through clinical histories and validated self-reports.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Mass Index-for-Age Z-score (BMI-for-age) | Baseline, 6 months, and 12 months | Mean change in BMI-for-age z-scores as per WHO AnthroPlus standards, measured at baseline, 6 months, and 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mid-Upper Arm Circumference (MUAC) | Baseline, 6 months, and 12 months | Mean change in mid-upper arm circumference (cm) measured using standard non-stretchable tape. |
| Change in cognitive function score (CFIT) | Baseline and 12 months | Change in cognitive function as assessed using the Culture Fair Intelligence Test (CFIT) at baseline and 12 months. |
Countries
Indonesia
Outcome results
None listed