Nutritional Support for Lactating Women and Azithromycin to Infants - Mumta Lactating Women Trial
Condition: Undernutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      A community-based, randomized control, assessor blinded trial in peri-urban settings of
      Karachi, Pakistan to study the impact of Lipid-based Nutritional Supplement for Pregnant and
      Lactating women which is balanced energy-protein (BEP) dietary supplement, a locally produced
      ready-to-use nutritional product for lactating women (LW) and single prophylaxis dose of
      Azithromycin for infants, on growth of infants over the period of six months since birth
      compared to current standard of care. LW and her infant will be enrolled in the trial within
      168 hours of the birth and LW will be randomized in either of the arm:

        1. Arm A: 'Control Arm', LW will only receive standard of care which comprises of standard
           nutritional counseling, key messages of exclusive breastfeeding, essential newborn and
           infant care and immunization.

        2. Arm B: 'Nutritional supplement only', LW randomized will recieve nutrition supplement
           product for next 6 months to be consumed in a dose of 2 sachets of 75 grams per day.
           Further, LW will also receive standard of care which comprises of standard nutritional
           counseling, key messages of exclusive breastfeeding, essential newborn and infant care
           and immunization.

        3. Arm C: ''Nutritional supplement plus Azithromycin', LW randomized will receive
           nutritional supplement product for next 6 months to be consumed in a dose of 2 sachets
           of 75 grams per day. Further, the infant of LW will receive a single dose of
           Azithromycin (20mg/kilogram) at day 42 of age. Further, LW will also receive standard of
           care which comprises of standard nutritional counseling, key messages of exclusive
           breastfeeding, essential newborn and infant care and immunization.

      Study aim is to assess the efficacy of nutritional product in a proposed dose to lactating
      women for at least 6 months of lactation, alone or in combination of single dose of
      Azithromycin as 20mg/kg to infants at 42 days of age on lenght velocity as primary, and
      weight velocity as secondary outcome.

      Participants will receive nutrition counseling along with guidance related to exclusive
      breastfeeding and further assessment will be done to assess breast milk composition,
      Haemoglobin, Ferritin and Transferrin receptor, and inflammatory biomarkers, as secondary
      outcomes. Further, this study will also look at the comparison of length-for-age,
      weight-for-length, and weight-for-age Z scores as other secondary outcome at 6 months of age
      among three arms.
    


Intervention name(s): Balanced energy-protein (BEP); Azithromycin
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Lactating women in the intervention arms will receive approximately 800 Kcal/day and around 16-21 gram of protein in a day in the form of ready-to-use supplement.; A single prophylaxis dose of 20 mg/kg in suspension form, reconstituted by trial staff before dose administration by the same.
Other intervention name(s): RUSF; Suspension
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment