NCT00885144

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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

June 24, 2009

Status Verified

June 1, 2009

Enrollment Period

2 months

First QC Date

April 20, 2009

Last Update Submit

June 23, 2009

Conditions

Malnutrition

Keywords

StuntingGrowth failureMalnutritionLipid based nutrient supplementLNSPreventionMalawiSub-Saharan AfricaDietary supplementation

Outcome Measures

Primary Outcomes (1)

  • Mean amount (in grammes) of test food consumed

    within 15 minutes of test feeding

Secondary Outcomes (3)

  • Mean time taken to consume the intervention dose

    15 minutes after test feeding

  • Mean rating by the guardians (on a hedonic, 5 point scale)

    15 minutes after test feeding

  • Overall guardian feedback after a two week supplementation period (qualitative analysis of focus group discussions)

    Once, when the children have completed a two-week supplementary feeding period

Interventions

NutributterDIETARY_SUPPLEMENT

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.

LNS-20gMDIETARY_SUPPLEMENT

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.

LNS-20gNoMDIETARY_SUPPLEMENT

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.

LNS-10gMDIETARY_SUPPLEMENT

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.

Eligibility Criteria

Age8 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Malawi, College of Medicine

Mangochi, Malawi

Location

Related Links

MeSH Terms

Conditions

MalnutritionGrowth DisordersFailure to Thrive

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Per Ashorn, MD, PhD

    Tampere University

    PRINCIPAL INVESTIGATOR

  • Kenneth Maleta, MBBS, PhD

    Kamuzu University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 21, 2009

Study Start

April 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

June 24, 2009

Record last verified: 2009-06

Locations

MA(1)