Skip to main content
OpenTrials
Completed

NCT Number: NCT00945698

Prevention of Linear Growth Failure in Infants and Young Children With Lipid-based Nutrient Supplements (iLiNS-DOSE)

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. Modified versions of such supplements have been developed to improve their nutrient density and quality and to lower their costs. Such modified products have proven acceptable to infants and their guardians in Malawi and Ghana. In the present trial, the investigator aim to identify the lowest growth-promoting daily dose of modified LNS. Additionally, the investigators will test a hypothesis that LNS that does not contain milk promotes growth as well as milk-containing LNS when given for 12 months at a 10-40 g daily dose to 6-18 month old infants in rural Malawi.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malnutrition Failure to Thrive Growth Disorders Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

167 day–197 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Malawi, College of Medicine

Mangochi, Malawi

About this study

Six-month old healthy infants are identified through community surveys in the study area. 1920 infants meeting set criteria are randomised into receiving the following intervention between 6 and 18 months of age: 1) standard treatment from 6-18 months (i.e.no supplements, with delayed intervention between 18-30 months of age (ST-DI), 2) 10 g / day milk-containing LNS (LNS-10gM), 3) 20 g / day milk-containing LNS (LNS-20gM), 4) 20 g / day milk-free LNS (LNS-20gNoM), 5) 40 g / day milk-containing LNS, (LNS-40gM) 6) 40 g / day milk-free LNS (LNS-40gNoM). The families receive the food supplements at 2-weekly intervals and the participants undergo a morbidity evaluation weekly, a limited development assessment at 4-weekly intervals and anthropometric evaluation at 26-week intervals and laboratory analyses at enrollment and at 18 months. Growth outcome analyses are done at 18 and at 42 months of age.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 Mangochi District Hospital or Namwera Health Centre catchment area

Exclusion criteria

  • Weight for length Z score (WLZ) < -2.0
  • Presence of oedema
  • Severe anaemia (Hb<50 g / l)
  • 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

Treatment and study plan

Lipid-based nutrient supplement, 10gM

Dietary Supplement
  • 140 g of milk-containing LNS (LNS-10gM) 2-weekly (10 g / day) between 6 and 18 months of age
  • Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring

Lipid-based nutrient supplement, 20gM

Dietary Supplement
  • 280 g of milk-containing LNS (LNS-20gM) 2-weekly (20 g / day) between 6 and 18 months of age
  • Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring

Lipid-based Nutrient Supplement, 20gNoM

Dietary Supplement
  • 280 g of milk-free LNS (LNS-20gNoM) 2-weekly (20 g / day) between 6 and 18 months of age
  • Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring

Lipid-based nutrient supplement, 40gM

Dietary Supplement
  • 560 g of milk-containing LNS (LNS-40gM) 2-weekly (40 g / day) between 6 and 18 months of age
  • Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring

Lipid-based Nutrient Supplement, 40gNoM

Dietary Supplement
  • 560 g of milk-free LNS (LNS-40gNoM) 2-weekly (40 g / day) between 6 and 18 months of age
  • Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring

Maize-soy flour

Dietary Supplement
  • No food supplement during the primary trial period (6 to 18 months of age)
  • 1 kg fortified maize / soy flour (Likuni phala, LP) 2-weekly (71 g / day) between 18 and 30 months of age
  • Normal under-five clinic follow-up, including EPI-vaccinations, vitamin A supplementation, and growth monitoring

Primary outcomes

  1. Change in length-for-age Z-score (LAZ, based on WHO 2005 MGRS) between enrollment and 18 months of age

    Time frame: Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)

  2. Incidence of serious adverse events during the study period

    Time frame: 12 months after enrollment (age 18 months)

Secondary outcomes

  1. Change in weight-for-age (WAZ) and weight-for-length (WLZ) Z-scores

    Time frame: Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)

  2. Incidence of stunting, underweight, and wasting

    Time frame: Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months)

  3. Prevalence of reduced appetite

    Time frame: Daily assessment during 12 month supplementation

  4. Energy intake from complementary foods

    Time frame: 3 and 9 months after enrollment (age 9 and 15 months)

  5. Incidence of laboratory-confirmed malaria infection

    Time frame: 12 months after enrollment (age 18 months)

  6. Incidence of caregiver-reported morbidity

    Time frame: Daily assessment during 12 month supplementation

  7. Immune function (measured by humoral immunity towards measles vaccination)

    Time frame: 12 months after enrollment (age 18 months)

  8. Change in hemoglobin and micronutrient status (iron status, measured by zinc protoporphyrin (ZPP); plasma zinc; plasma vitamin A; B-vitamins and related metabolites; urine iodine

    Time frame: 12 months after enrollment (age 18 months)

  9. Proportion with anaemia at 18 months of age

    Time frame: 12 months after enrollment (age 18 months)

  10. Change in erythrocyte essential fatty acid (EFA) concentration (measured from a subsample of 400 participants)

    Time frame: 12 months after enrollment (age 18 months)

  11. Neuro-behavioral development (timing of acquisition of the certain skills and more comprehensive analysis at the age of 18 months)

    Time frame: Limited assessment every 4 weeks during the 12 months supplementation, more comprehensive at age 18 months

  12. Incidence of all adverse events during the study period

    Time frame: 12 months after enrollment (age 18 months)

Sponsors and collaborators

Lead sponsor

Tampere University

Other

Collaborators

  • Bill and Melinda Gates Foundation
  • Kamuzu University of Health Sciences
  • University of California, Davis

Registry information

Official study title

A Two-centre, Randomised, Single-blind, Parallel Group Controlled Trial, Testing the Growth Promoting Effect of Long-term Complementary Feeding of Infants With Different Doses and Formulations of Lipid-based Nutrient Supplements (LNS)

Acronym: iLiNS-DOSE

Important dates

Study start
2009
Primary completion
2012
Study completion
2014
First posted
Jul 24, 2009
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.