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NCT Number: NCT07451951

Effectiveness of Small-Quantity vs Medium-Quantity Lipid-Based Nutrient Supplements for Prevention of Undernutrition in Children 6-24 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-led multisectoral nutrition program under the 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 6 to 24 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.

The study is being conducted in Dadu and Peshawar, Pakistan. Participants in Dadu will be followed until 24 months of age, while participants in Peshawar will be followed until 12 months of age.

Participants will:

* Receive either SQ-LNS or MQ-LNS once daily until 24 months of age (Dadu) or 12 months of age (Peshawar) * Have their length, weight and mid-upper arm circumference (MUAC) measured monthly * Have their blood screened for anemia at enrollment and at 12 and 24 months of age (Dadu) or at enrollment and 12 months of age (Peshawar)

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Key information

Conditions

Undernutrition Anemia Body Weight Body Weight Changes Cachexia Growth Disorders Hematologic Diseases Hemic and Lymphatic Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Weight Loss

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

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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: Dadu: monthly from enrollment to 24 months of participant's age Peshawar: monthly from enrollment to 12 months of participant's age

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

Secondary outcomes

  1. Wasting

    Time frame: Dadu: monthly from enrollment to 24 months of participant's age Peshawar: monthly from enrollment to 12 months of participant's age

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

  2. Underweight

    Time frame: Dadu: monthly from enrollment to 24 months of participant's age Peshawar: monthly from enrollment to 12 months of participant's age

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

  3. Morbidity

    Time frame: Dadu: monthly from enrollment to 24 months of participant's age Peshawar: monthly from enrollment to 12 months of participant's age

    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: Dadu: at enrollment and later at 12 and 24 months of participant's age. Peshawar: at enrollment and later at 12 months of participant's age.

    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 6-24 Months: An Individually Randomized, Parallel-Group, Non-Inferiority Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 5, 2026
Registry last updated
Aug 12, 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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