Nutritional Support for Lactating Women and Azithromycin to Infants - Mumta Lactating Women Trial
Status:
Completed
Trial end date:
2020-11-20
Target enrollment:
Participant gender:
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.