Prevention of Linear Growth Failure in Infants and Young Children With Lipid-based Nutrient Supplements (iLiNS-DOSE) (iLiNS-DOSE)
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ClinicalTrials.gov Identifier: NCT00945698 |
Recruitment Status :
Completed
First Posted : July 24, 2009
Last Update Posted : May 27, 2015
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Condition or disease | Intervention/treatment | Phase |
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Malnutrition | Dietary Supplement: Lipid-based nutrient supplement, 10gM Dietary Supplement: Lipid-based nutrient supplement, 20gM Dietary Supplement: Lipid-based Nutrient Supplement, 20gNoM Dietary Supplement: Lipid-based nutrient supplement, 40gM Dietary Supplement: Lipid-based Nutrient Supplement, 40gNoM Dietary Supplement: Maize-soy flour | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1920 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Prevention |
Official 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) |
Study Start Date : | November 2009 |
Actual Primary Completion Date : | August 2012 |
Actual Study Completion Date : | August 2014 |

Arm | Intervention/treatment |
---|---|
ST-DI (Delayed intervention)
|
Dietary Supplement: Maize-soy flour
|
Experimental: LNS-10gM
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Dietary Supplement: Lipid-based nutrient supplement, 10gM
|
Experimental: LNS-20gM
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Dietary Supplement: Lipid-based nutrient supplement, 20gM
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Experimental: LNS-20gNoM
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Dietary Supplement: Lipid-based Nutrient Supplement, 20gNoM
|
Experimental: LNS-40gM
|
Dietary Supplement: Lipid-based nutrient supplement, 40gM
|
Experimental: LNS-40gNoM
|
Dietary Supplement: Lipid-based Nutrient Supplement, 40gNoM
|
- 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) ]
- Incidence of serious adverse events during the study period [ Time Frame: 12 months after enrollment (age 18 months) ]
- 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) ]
- Incidence of stunting, underweight, and wasting [ Time Frame: Primarily 12 months after enrollment (age 18 months), secondarily 36 months after enrollment (age 42 months) ]
- Prevalence of reduced appetite [ Time Frame: Daily assessment during 12 month supplementation ]
- Energy intake from complementary foods [ Time Frame: 3 and 9 months after enrollment (age 9 and 15 months) ]
- Incidence of laboratory-confirmed malaria infection [ Time Frame: 12 months after enrollment (age 18 months) ]
- Incidence of caregiver-reported morbidity [ Time Frame: Daily assessment during 12 month supplementation ]
- Immune function (measured by humoral immunity towards measles vaccination) [ Time Frame: 12 months after enrollment (age 18 months) ]
- 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) ]
- Proportion with anaemia at 18 months of age [ Time Frame: 12 months after enrollment (age 18 months) ]
- Change in erythrocyte essential fatty acid (EFA) concentration (measured from a subsample of 400 participants) [ Time Frame: 12 months after enrollment (age 18 months) ]
- 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 ]
- Incidence of all adverse events during the study period [ Time Frame: 12 months after enrollment (age 18 months) ]

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Ages Eligible for Study: | 167 Days to 197 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945698
Malawi | |
University of Malawi, College of Medicine | |
Mangochi, Malawi |
Principal Investigator: | Per Ashorn, MD, PhD | University of Tampere Medical School | |
Principal Investigator: | Kenneth Maleta, MBBS, PhD | University of Malawi College of Medicine |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Per Ashorn, Professor of International Health, Tampere University |
ClinicalTrials.gov Identifier: | NCT00945698 |
Other Study ID Numbers: |
iLiNS-DOSE |
First Posted: | July 24, 2009 Key Record Dates |
Last Update Posted: | May 27, 2015 |
Last Verified: | May 2015 |
Stunting Growth failure Malnutrition Lipid based nutrient supplement LNS |
Prevention Malawi Sub-Saharan Africa Dietary supplementation Efficacy |
Malnutrition Nutrition Disorders Nutrients Growth Substances Physiological Effects of Drugs |