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Sponsors and Collaborators: |
University of Tampere University of Malawi College of Medicine University of California, Davis Bill and Melinda Gates Foundation |
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Information provided by: | University of Tampere |
ClinicalTrials.gov Identifier: | NCT00885144 |
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. The investigators' study group has developed modified versions of such supplements that theoretically will supplement infants diets better and with lower cost. As a preparation for larger efficacy trials, the investigators now aim to test the acceptability of these supplements among Malawian infants and their guardians. The trial hypothesis is that the infants will consume on average at least 50% of an offered dose that consists of LNS mixed with maize porridge.
Condition | Intervention | Phase |
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Malnutrition |
Dietary Supplement: Nutributter Dietary Supplement: LNS-20gM Dietary Supplement: LNS-20gNoM Dietary Supplement: LNS-10gM |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Crossover Assignment |
Official Title: | Differential Acceptability of New Lipid Based Nutrient Supplement (LNS) Formulations for Prevention of Moderate Malnutrition |
Enrollment: | 19 |
Study Start Date: | April 2009 |
Study Completion Date: | June 2009 |
Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
In the first phase, 18 infants meeting set criteria are randomised into receiving three test meals with novel LNS preparations over a three-day period. The meals will consists of the following, each given on one day and in a random order: 1) 7.5 g of LNS-10gM mixed in 30 g maize-soy porridge, 2) 15 g of LNS-20gM mixed in 30 g maize-soy porridge, 3) 15 g of LNS-20gNoM mixed in 30 g maize-soy porridge. As a run in procedure, each participant will undergo a test feeding session with one of the the test foods on the day before the actual test-feeding period.
As a positive control, each participant will undergo test feeding session with standard Nutributter (NB) on the day after the actual test-feeding period.
In the second phase a set of 48 infants are randomised into 3 groups receiving the following food supplements for a period of 2 weeks: 1) 10 g/day of milk-containing, very concentrated LNS (LNS-10gM), 2) 20 g/day of milk-containing, concentrated LNS (LNS-20gM), 3) 20 g/day of milk-free, concentrated LNS (LNS-20 g NoM)
Outcomes measures in the first phase will be assessed through safety reports and quantities of test food consumed by the child and a hedonic scale of acceptability by the mothers of the children. The second phase will be assessed with qualitative outcomes, from data obtained from focus group discussions with the guardians of the infants consuming the test foods.
Ages Eligible for Study: | 8 Months to 12 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Malawi | |
University of Malawi, College of Medicine | |
Mangochi, Malawi |
Principal Investigator: | Per Ashorn, MD, PhD | University of Tampere |
Principal Investigator: | Kenneth Maleta, MBBS, PhD | University of Malawi College of Medicine |
Responsible Party: | University of Tampere ( Per Ashorn / Professor of International Health ) |
Study ID Numbers: | iLiNS-ACCEPT-M |
Study First Received: | April 20, 2009 |
Last Updated: | June 23, 2009 |
ClinicalTrials.gov Identifier: | NCT00885144 History of Changes |
Health Authority: | Malawi: College of Medicine Research and Ethics Committee |
Stunting Growth failure Malnutrition Lipid based nutrient supplement LNS |
Prevention Malawi Sub-Saharan Africa Dietary supplementation |
Malnutrition Nutrition Disorders |
Malnutrition Nutrition Disorders |