Status:
ACTIVE_NOT_RECRUITING
Supplementing Maternal and Infant Diet With High-energy, Micronutrient Fortified Lipid-based Nutrient Supplements (LNS)
Lead Sponsor:
Tampere University
Collaborating Sponsors:
Kamuzu University of Health Sciences
University of California, Davis
Conditions:
Infant Malnutrition
Malnutrition in Pregnancy
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief Summary
The use of lipid-based nutrients (LNS), such as Nutributter or fortified spread (FS), have been associated with improved growth and development outcomes among infants in Ghana and Malawi. Modified ver...
Detailed Description
Pregnant women will be identified from the antenatal clinics of 4 governmental and 2 other health centres. A total of 1400 women meeting set criteria will be randomised into receiving one of the follo...
Eligibility Criteria
Inclusion
- Ultrasound confirmed pregnancy of no more than 20 completed gestation weeks
- Permanent resident of Mangochi District Hospital, Malindi Hospital or Lungwena Health Centre catchment areas
- Availability during the period of the study
- Signed informed consent
Exclusion
- Less than 15 years of age
- Need for frequent medical attention due to a chronic health condition
- Diagnosed asthma treated with regular medication
- Severe illness warranting hospital referral
- History of allergy towards peanuts
- History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
- Pregnancy complications evident at enrolment visit (moderate to severe oedema, blood Hb concentration \< 5 g / dl, systolic blood pressure (BP) \> 160 mmHg or diastolic BP \> 100 mmHg)
- Earlier participation in the iLiNS-DYAD-M trial
- Concurrent participation in any other clinical trial
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2027
Estimated Enrollment :
1391 Patients enrolled
Trial Details
Trial ID
NCT01239693
Start Date
February 1 2011
End Date
March 31 2027
Last Update
March 28 2025
Active Locations (1)
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1
University of Malawi, College of Medicine
Mangochi, Malawi