NCT00524446

Brief Summary

This study tests the hypothesis that infants receiving milk-powder containing fortified spread (lipid-based nutrient supplement) as a complementary food for one year have lower incidence of severe stunting (poor length gain) than infants who are provided with no extra food supplements or maize-soy flour for complementary porridge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
840

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_3

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

First Submitted

Initial submission to the registry

August 31, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

May 21, 2014

Status Verified

May 1, 2014

Enrollment Period

3.4 years

First QC Date

August 31, 2007

Last Update Submit

May 20, 2014

Conditions

MalnutritionStuntingDevelopmental Delay

Keywords

InfantSub-Saharan AfricaComplementary feedingFortified spreadLipid-based nutrient supplementMalnutritionStuntingGrowthMorbidityDevelopmentHaemoglobin

Outcome Measures

Primary Outcomes (2)

  • Incidence of severe stunting (Length-for-age Z score < -3)

    1 year after enrolment

  • Incidence of serious and non-serious adverse events

    1 year

Secondary Outcomes (9)

  • Incidence of moderate or severe stunting (Length-for-age Z-score < -2)

    1 year

  • Length gain (cm)

    1 year

  • Weight gain (g)

    1 year

  • Change in anthropometric indices (Weight-for-age Z-score, Weight-for-length Z-score, Length-for-age Z-score), mid-upper arm circumference and head circumference

    1 year

  • Incidence of moderate or severe underweight or wasting (Weight-for-age Z-score or Weight-for-length Z-score <-2 / -3 SD units)

    1 year

  • +4 more secondary outcomes

Study Arms (4)

ST-DI

NO INTERVENTION

Standard treatment - delayed intervention. Counselling on complementary feeding + Vitamin A (200,000 IU) every 6 months until 36 months + 1 kg maize / soy flour 2-weekly (71 g / day) between 18 and 30 months of age.

FSm

EXPERIMENTAL

Fortified Spread (milk). Counseling + Vitamin A as for ST-DI + 750 g of fortified spread (FSm) 2-weekly (54 g / day) between 6 and 18 months of age.

Dietary Supplement: Milk-containing fortified spread

FSs

EXPERIMENTAL

Counselling + Vitamin A as for ST-DI + 750 g of modified fortified spread (FSs) 2-weekly (54 g / day) between 6 and 18 months of age.

Dietary Supplement: Soy-containing fortified spread

LP

EXPERIMENTAL

Likuni Phala. Counseling + Vitamin A as for ST-DI + 1 kg fortified maize / soy flour 2-weekly (71 g / day) between 6 and 18 months of age.

Dietary Supplement: Maize-soy flour

Interventions

Milk-containing fortified spreadDIETARY_SUPPLEMENT

Counseling + Vitamin A as for ST-DI + 750 g of fortified spread (FSm) 2-weekly (54 g / day) between 6 and 18 months of age.

FSm
Soy-containing fortified spreadDIETARY_SUPPLEMENT

Counseling + Vitamin A as for ST-DI + 750 g of modified fortified spread (FSs) 2-weekly (54 g / day) between 6 and 18 months of age.

FSs
Maize-soy flourDIETARY_SUPPLEMENT

Counseling + Vitamin A as for ST\_DI + 1 kg fortified maize / soy flour 2-weekly (71 g / day) between 6 and 18 months of age.

LP

Eligibility Criteria

Age6 Months - 6 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Signed informed consent from at least one guardian
  • Age 5.50 months to 6.49 months
  • Availability during the period of the study.
  • Permanent resident of Lungwena Health Centre or Malindi Hospital catchment area

You may not qualify if:

  • Existing or imminent severe stunting (HAZ \< -2.8)
  • Weight for length (WFH) \< 80% of the reference median or presence of oedema
  • Severe illness warranting hospital referral.
  • History of allergy towards peanut
  • History of anaphylaxis or serious allergic reaction to any substance, requiring emergency medical care
  • Concurrent participation in any other clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

College of Medicine, University of Malawi

Mangochi, Malawi

Location

Related Publications (4)

  • Xu G, Davis JC, Goonatilleke E, Smilowitz JT, German JB, Lebrilla CB. Absolute Quantitation of Human Milk Oligosaccharides Reveals Phenotypic Variations during Lactation. J Nutr. 2017 Jan;147(1):117-124. doi: 10.3945/jn.116.238279. Epub 2016 Oct 19.

    PMID: 27798342DERIVED

  • Aakko J, Grzeskowiak L, Asukas T, Paivansade E, Lehto KM, Fan YM, Mangani C, Maleta K, Ashorn P, Salminen S. Lipid-based Nutrient Supplements Do Not Affect Gut Bifidobacterium Microbiota in Malawian Infants: A Randomized Trial. J Pediatr Gastroenterol Nutr. 2017 Apr;64(4):610-615. doi: 10.1097/MPG.0000000000001333.

    PMID: 27403608DERIVED

  • Mangani C, Ashorn P, Maleta K, Phuka J, Thakwalakwa C, Dewey K, Manary M, Puumalainen T, Cheung YB. Lipid-based nutrient supplements do not affect the risk of malaria or respiratory morbidity in 6- to 18-month-old Malawian children in a randomized controlled trial. J Nutr. 2014 Nov;144(11):1835-42. doi: 10.3945/jn.114.196139. Epub 2014 Sep 17.

    PMID: 25332483DERIVED

  • Grzeskowiak L, Collado MC, Mangani C, Maleta K, Laitinen K, Ashorn P, Isolauri E, Salminen S. Distinct gut microbiota in southeastern African and northern European infants. J Pediatr Gastroenterol Nutr. 2012 Jun;54(6):812-6. doi: 10.1097/MPG.0b013e318249039c.

    PMID: 22228076DERIVED

Related Links

MeSH Terms

Conditions

MalnutritionGrowth DisordersLearning Disabilities

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Per Ashorn, MD, PhD

    University of Tampere Medical School, Finland

    STUDY DIRECTOR

  • Kenneth Maleta, MBBS, PhD

    Kamuzu University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of International Health

Study Record Dates

First Submitted

August 31, 2007

First Posted

September 3, 2007

Study Start

January 1, 2008

Primary Completion

June 1, 2011

Study Completion

January 1, 2014

Last Updated

May 21, 2014

Record last verified: 2014-05

Locations

MA(1)