Medium-quantity lipid-based nutrient supplement (MQ-LNS)
Dietary Supplement50 g/day lipid-based nutrient supplement providing energy and essential micronutrients, administered daily for 6 months.
NCT Number: NCT07451951
Nutrition is essential for a child's growth, brain development, and protection from disease. While breastmilk provides the best nutrition for young infants, children older than six months may not get all the nutrients they need from breastmilk and regular foods alone. For this reason, some children receive special nutrient supplements to support healthy growth.
Lipid-based nutrient supplements (LNS) are one type of supplement that provides important vitamins and minerals. These supplements are used in many countries to help prevent undernutrition in young children. In Pakistan, the government social safety net program currently provides medium-quantity LNS to children starting at six months of age. However, it is not known whether a smaller-quantity LNS could provide similar benefits for children in this age group from under-resourced communities that have limited access to nutritious foods.
The goal of this trial is to learn whether small-quantity lipid-based nutrient supplements (SQ-LNS) work as well as medium-quantity lipid-based nutrient supplements (MQ-LNS) in preventing undernutrition in children aged six to twelve months.
The main questions this study aims to answer are:
* Does SQ-LNS work as well as MQ-LNS in supporting healthy growth, including reducing stunting, wasting, and underweight? * Does SQ-LNS work as well as MQ-LNS in reducing anemia?
Researchers will compare SQ-LNS and MQ-LNS to see if SQ-LNS is as good as MQ-LNS in preventing undernutrition.
Participants will:
* Receive either SQ-LNS or MQ-LNS once daily for 6 months * Have their length, weight and mid-upper arm circumference (MUAC) measured monthly * Have their blood tested for anemia at the start and end of supplementation
Interested in participating?
Request Info26 week–33 week
All sexes
Interventional
Not applicable
BNP Facilitation Centers, Peshawar, Khyber Pakhtunkhwa, Pakistan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
50 g/day lipid-based nutrient supplement providing energy and essential micronutrients, administered daily for 6 months.
20 g/day lipid-based nutrient supplement providing energy and essential micronutrients, administered daily for 6 months.
Time frame: From enrollment to the end of intervention period at 6 months
length-for-age z-score (LAZ) < -2 SD
Time frame: From enrollment to the end of intervention period at 6 months
weight-for-length z-score (WLZ) < -2 SD
Time frame: From enrollment to the end of intervention period at 6 months
weight-for-age z-score (WAZ) < -2 SD
Time frame: From enrollment to the end of intervention period at 6 months
Includes diarrhea (liquid stools defined as ≥3 loose or watery stools within 24 hour), respiratory infection (cough plus rapid, difficult breathing), vomiting, fever, rash/sores, coughing, wheezing and pneumonia.
Time frame: At enrollment and later at the end of intervention period at 6 months
hemoglobin <11 g/dL.
For mild anemia: hemoglobin 10.0 - 10.9 g/dL For moderate anemia: 7.0 - 9.9 g/dL For severe anemia: <7.0 g/dL
Aga Khan University
Other
Effectiveness of Small-Quantity vs Medium-Quantity Lipid-Based Nutrient Supplements for Prevention of Undernutrition in Children Aged 6-12 Months: An Individually Randomized, Parallel-Group, Non-Inferiority Trial
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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.
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