Trial on the Acceptability of Modified Lipid Based Nutrient Supplements Among Malawian Infants (iLiNS-ACCEPT-M)

This study has been completed.
Sponsor:
Collaborators:
University of Malawi College of Medicine
University of California, Davis
Bill and Melinda Gates Foundation
Information provided by:
University of Tampere
ClinicalTrials.gov Identifier:
NCT00885144
First received: April 20, 2009
Last updated: June 23, 2009
Last verified: June 2009
  Purpose

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
Malnutrition
Dietary Supplement: Nutributter
Dietary Supplement: LNS-20gM
Dietary Supplement: LNS-20gNoM
Dietary Supplement: LNS-10gM
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Differential Acceptability of New Lipid Based Nutrient Supplement (LNS) Formulations for Prevention of Moderate Malnutrition

Resource links provided by NLM:


Further study details as provided by University of Tampere:

Primary Outcome Measures:
  • Mean amount (in grammes) of test food consumed [ Time Frame: within 15 minutes of test feeding ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean time taken to consume the intervention dose [ Time Frame: 15 minutes after test feeding ] [ Designated as safety issue: No ]
  • Mean rating by the guardians (on a hedonic, 5 point scale) [ Time Frame: 15 minutes after test feeding ] [ Designated as safety issue: No ]
  • Overall guardian feedback after a two week supplementation period (qualitative analysis of focus group discussions) [ Time Frame: Once, when the children have completed a two-week supplementary feeding period ] [ Designated as safety issue: No ]

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)
Intervention Details:
    Dietary Supplement: Nutributter
    Test dose of "standard" supplementary lipid based nutrient supplement (LNS). 15 grams of Nutributter will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.
    Dietary Supplement: LNS-20gM
    Test dose of modified LNS-20gM supplementary lipid based nutrient supplement (LNS). 15 grams of LNS-20gM will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.
    Dietary Supplement: LNS-20gNoM
    Test dose of modified LNS-20gNoM (milk free) supplementary lipid based nutrient supplement (LNS). 15 grams of LNS-20gNoM will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.
    Dietary Supplement: LNS-10gM
    Test dose of modified LNS-10gM supplementary lipid based nutrient supplement (LNS). 15 grams of LNS-10gM will be mixed with 30 g of maize porridge and fed to the child over a maximum of 15 minute period, under direct observation.
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   8 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent from at least one guardian
  • Age 7.50 months to 11.49 months
  • Currently breastfeeding
  • Consuming complementary feeds at least 30 days prior to enrollment
  • Availability during the period of the study

Exclusion Criteria:

  • Weight for length Z score (WFH) ≤ -2.0 using WHO growth reference standards or the -presence of oedema
  • Severe systemic illness warranting hospital referral
  • History of allergy towards peanut
  • History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
  • Congenital malformation such as cleft palate which may interfere with food intake
  • Concurrent participation in any other clinical trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885144

Locations
Malawi
University of Malawi, College of Medicine
Mangochi, Malawi
Sponsors and Collaborators
University of Tampere
University of Malawi College of Medicine
University of California, Davis
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Per Ashorn, MD, PhD University of Tampere
Principal Investigator: Kenneth Maleta, MBBS, PhD University of Malawi College of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Per Ashorn / Professor of International Health, University of Tampere
ClinicalTrials.gov Identifier: NCT00885144     History of Changes
Other Study ID Numbers: iLiNS-ACCEPT-M
Study First Received: April 20, 2009
Last Updated: June 23, 2009
Health Authority: Malawi: College of Medicine Research and Ethics Committee

Keywords provided by University of Tampere:
Stunting
Growth failure
Malnutrition
Lipid based nutrient supplement
LNS
Prevention
Malawi
Sub-Saharan Africa
Dietary supplementation

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on August 26, 2014