NCT05311436 Nutri-CAP: Nutrition for Children, Adolescent Girls, and Pregnant Women in Slums of Dhaka City
| NCT ID | NCT05311436 |
| Status | Recruiting |
| Phase | — |
| Sponsor | International Centre for Diarrhoeal Disease Research, Bangladesh |
| Condition | Gestational Weight Gain |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,278 participants |
| Start Date | 2022-04-01 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,278 participants in total. It began in 2022-04-01 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of the research project is to establish an evidence-based sustainable nutrition service delivery platform for optimizing pregnancy weight gain, increasing dietary diversity of adolescent girls, and ensuring proper physical growth of under 2 children. Hypothesis 1. Pregnant Women: Intensive nutrition and WASH counseling, iron-folate, calcium supplementation during pregnancy, can improve gestational weight gain and improve hemoglobin status in pregnant women in a slum of Dhaka city 2. Adolescent girl: Iron and zinc supplementation and nutrition counseling on dietary diversity could improve nutritional status and dietary diversity score in adolescent girls of slums in Dhaka 3. Children \<2 years: Counselling on IYCF, growth monitoring, and promotion, ensuring six-monthly vitamin A supplementation, counseling on WASH, treatment of acute malnutrition, and daily 1 egg supplementation for 3 months for severely stunted children can improve the nutritional status of children 4. Counselling to improve Water, Sanitation and Hygiene (WASH) practice: WASH intervention can improve EED biomarkers
Eligibility Criteria
Inclusion Criteria: * Pregnant women: * Age 18-39 years * Before 16 weeks of gestation * BMI 15-24.99 kg/m2 measured on enrolment * Have the plan to stay in the study area till delivery * Willing to participate in the study * Not enrolled in any nutrition project/programme currently Adolescent girls: * Aged 11-19 years * Willing to participate in the study * Not involved in any nutrition project/programme * Will stay in the study area for the next 2 years Children: * Aged 0-24 months * Youngest child of the household * Caregivers have the plan to stay in the study area at least up to two years of age * Not enrolled in any nutrition project/programme currently Exclusion Criteria: * Pregnant women: * Subject not willing to provide consent * Subject has the plan to migrate outside of the study area during the study period * Subject has a plan to go elsewhere ( village/ parents' house) for delivery * Any reported/diagnosed chronic diseases (such as hypertension, heart disease, chronic obstructive pulmonary disease, chronic kidney disease, chronic liver disease, pancreatic diseases, diabetes mellitus, thyroid dysfunction, immunological diseases, malignancy, or any other diseases which could impede compliance with the study protocol) * Extremely obese * Subject involved in any nutrition programme/ intervention currently Adolescent girls: * Subject not willing to give assent/consent * Subject has the plan to migrate outside the study area during the study period * Subject involved in any nutrition programme/intervention currently Children: * Caregiver/guardian not willing to provide consent * Have the plan to migrate outside of the study area during the study period * Child with any congenital anomaly * Subject involved in any nutrition programme/intervention currently
Contact & Investigator
Mustafa Mahfuz, MBBS, MPH, PhD
PRINCIPAL INVESTIGATOR
International Centre for Diarrhoeal Disease Research, Bangladesh
Frequently Asked Questions
Who can join the NCT05311436 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 39 Years, studying Gestational Weight Gain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05311436 currently recruiting?
Yes, NCT05311436 is actively recruiting participants. Contact the research team at mustafa@icddrb.org for enrollment information.
Where is the NCT05311436 trial being conducted?
This trial is being conducted at Dhaka, Bangladesh.
Who is sponsoring the NCT05311436 clinical trial?
NCT05311436 is sponsored by International Centre for Diarrhoeal Disease Research, Bangladesh. The principal investigator is Mustafa Mahfuz, MBBS, MPH, PhD at International Centre for Diarrhoeal Disease Research, Bangladesh. The trial plans to enroll 3,278 participants.