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AzTrials

MalnutritionPhase 3LCNI-5NCT00524446

Controlled Trial to Test the Efficacy of Lipid-based Nutrient Supplements to Prevent Severe Stunting Among Infants

A Phase 3 study testing Milk-containing fortified spread, Soy-containing fortified spread and Maize-soy flour in people with Malnutrition and Stunting, run by Tampere University at 1 site in Malawi.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 6 monthsHealthy volunteers can take part
Conditions the study is for
Malnutrition, Stunting, Developmental Delay
What is being tested?
Milk-containing fortified spread, Soy-containing fortified spread and Maize-soy flour
Could I receive a placebo?
No, everyone receives an active treatment
How many people
840 participants
Where
1 siteMalawi
Study dates
Jan 2008to Jan 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 6 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Malawi1 site

  • College of Medicine, University of Malawi

    Mangochi

Other trials in Malawi

About this study

Official title: A Single-centre, Randomised, Single-blind, Parallel Group Clinical Trial in Rural Malawi, Testing the Growth Promoting Effect of Long-term Complementary Feeding of Infants With a High-energy, Micronutrient Fortified Spread

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.

Read the detailed description

Poor growth and severe childhood stunting is very common in rural Malawi and elsewhere in Sub-Sahara Africa. To date, few interventions have proven successful in promoting linear growth in early childhood. Our preliminary results from Malawi suggest that a year-long daily complementary feeding of infants with a high-energy, micronutrient-fortified spread (FS) may markedly reduce the incidence of severe stunting before the age of 18 months. In the present study the investigators will more carefully analyze the efficacy in linear growth promotion and other health benefits of this product when provided as a complementary food to infants between 6 and 18 months of age.

The study will be conducted in Lungwena area, Mangochi District, rural Malawi. Six-month old healthy infants are identified through community surveys in the study area. 840 infants meeting set criteria are randomized into receiving the following intervention between 6 and 18 months of age: 1) standard treatment ie no extra food supplements (but dietary supplementation between 18 and 30 months of age) (ST-DI, control group), 2), "standard" fortified spread with milk-powder as the protein source (FSm), 3) modified fortified spread with soy-powder as the protein source (FSs), or 4) fortified maize-soy flour (likuni phala, LP). The families receive the food supplements at 2-weekly intervals and the participants undergo an anthropometric and developmental evaluation and laboratory analyses at 12-week intervals. Outcome analyses are done at 18 and at 36 months of age.

The impact of the dietary interventions will be primarily assessed by comparing the incidence of severe stunting in the four study groups. Secondary outcomes include a number of anthropometric variables, morbidity, developmental milestones, and laboratory parameters. The study will also produce descriptive data on possible mechanisms for growth failure among the trial subjects.

Being tested
Milk-containing fortified spread, Soy-containing fortified spread, Maize-soy flour
Keywords
Infant, Sub-Saharan Africa, Complementary feeding, Fortified spread, Lipid-based nutrient supplement, Malnutrition, Stunting, Growth, Morbidity, Development, Haemoglobin
Medical subject headings
Malnutrition, Growth Disorders, Learning Disabilities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

  • 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.

Study groups in NCT00524446
Study groupRoleWhat they receive
ST-DINo interventionStandard 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.
FSmExperimentalFortified 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.
Receives: Dietary Supplement: Milk-containing fortified spread
FSsExperimentalCounselling + 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.
Receives: Dietary Supplement: Soy-containing fortified spread
LPExperimentalLikuni 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.
Receives: Dietary Supplement: Maize-soy flour

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 year after enrolment

  2. Incidence of serious and non-serious adverse events

    Measured: 1 year

Secondary outcomes (9)

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

    Measured: 1 year

  2. Length gain (cm)

    Measured: 1 year

  3. Weight gain (g)

    Measured: 1 year

  4. 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

    Measured: 1 year

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

    Measured: 1 year

  6. Blood haemoglobin, serum ferritin, vitamin A, and zinc concentration

    Measured: 18 months of age

  7. Motor, social, and language development (timing of acquisition of defined skills)

    Measured: 1 year

  8. Incidence of febrile illnesses and laboratory diagnosed malaria

    Measured: 1 year

  9. Morbidity for respiratory infections, diarrhea, and other illnesses

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2007 (estimated)
  2. Study startJan 2008
  3. Primary completionJun 2011
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
840 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00524446
Sponsor's protocol ID
LTS-2007-02-19
Acronym
LCNI-5
Status last verified
May 2014
First submitted
31 Aug 2007
Last updated
21 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 27798342

  • 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.

    PubMed 27403608

  • 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.

    PubMed 25332483

  • 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.

    PubMed 22228076

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Milk-containing fortified spread, Soy-containing fortified spread and Maize-soy flour in people with Malnutrition and Stunting, run by Tampere University at 1 site in Malawi.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of severe stunting (Length-for-age Z score < -3) (time frame: 1 year after enrolment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00524446, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2014.

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