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NCT Number: NCT07451951

Effectiveness of Small-Quantity vs Medium-Quantity Lipid-Based Nutrient Supplements for Prevention of Undernutrition in Children 6-12 Months

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

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Key information

Age range

26 week–33 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BNP Facilitation Centers, Peshawar, Khyber Pakhtunkhwa, Pakistan

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children aged 6 months (26 weeks) to 7 months and 15 days (33 weeks) with weight-for-length z-score (WLZ) ≥ -2 standard deviation (SD) and mid-upper arm circumference (MUAC) ≥125 mm, born to mothers who are beneficiaries of the Benazir Income Support Programme and registered with the Benazir Nashonuma Programme (BNP) at any point during their pregnancy.
  • Permanent residents of the selected districts, with no plan to relocate or migrate within the next 6 months.
  • Written informed consent provided by the child's caregivers.

Exclusion criteria

  • Children with moderate acute malnutrition (MAM), defined as WLZ ≥ -3 to < -2 SD, or MUAC ≥115 mm to <125 mm.
  • Children with severe acute malnutrition (SAM), defined as WLZ < -3 SD or MUAC <115 mm or presence of bilateral pitting edema, who require therapeutic feeding.
  • Children with known congenital anomalies, chronic illness, or conditions affecting growth or feeding (for example, cerebral palsy or congenital heart disease).
  • Children already enrolled in any nutritional supplementation other than BNP or another clinical trial.
  • Children whose families will be unwilling to provide informed consent, or likely to be unavailable for follow-up.

Treatment and study plan

Medium-quantity lipid-based nutrient supplement (MQ-LNS)

Dietary Supplement

50 g/day lipid-based nutrient supplement providing energy and essential micronutrients, administered daily for 6 months.

Small-quantity lipid-based nutrient supplement (SQ-LNS)

Dietary Supplement

20 g/day lipid-based nutrient supplement providing energy and essential micronutrients, administered daily for 6 months.

Primary outcomes

  1. Stunting

    Time frame: From enrollment to the end of intervention period at 6 months

    length-for-age z-score (LAZ) < -2 SD

Secondary outcomes

  1. Wasting

    Time frame: From enrollment to the end of intervention period at 6 months

    weight-for-length z-score (WLZ) < -2 SD

  2. Underweight

    Time frame: From enrollment to the end of intervention period at 6 months

    weight-for-age z-score (WAZ) < -2 SD

  3. Morbidity

    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.

  4. Prevalence of anemia

    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

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

  • Benazir Income Support Programme (BISP)
  • United Nations World Food Programme (WFP)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 5, 2026
Registry last updated
Jun 2, 2026

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.

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