NCT03564652: MumtaLW

Nutritional Support for Lactating Women and Azithromycin to Infants - Mumta Lactating Women Trial

Completed NA Last updated 26 January 2021

What this trial tests

NA trial testing Balanced energy-protein (BEP) in Undernutrition in 957 participants. Completed in 20 November 2020.

Timeline

1 August 2018

Primary endpoint
20 November 2020

20 November 2020

Quick facts

Lead sponsor	Vital Pakistan Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	957
Start date	1 August 2018
Primary completion	20 November 2020
Estimated completion	20 November 2020
Sites	1 location across Pakistan

Drugs / interventions tested

• Balanced energy-protein (BEP)
• Azithromycin (azithromycin) — full drug profile →

Conditions studied

• Undernutrition — all drugs for Undernutrition →

Sponsor

Vital Pakistan Trust

Who can join

Adults 13 to 49, female only, with Undernutrition. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antimicrobial Resistance Following Azithromycin Mass Drug Administration: Potential Surveillance Strategies to Assess Public Health Impact.
   Mack I, Sharland M, Berkley JA, Klein N, et al · · 2020 · cited 31× · PMID 31633161 · DOI 10.1093/cid/ciz893
2. Mass azithromycin administration: considerations in an increasingly resistant world.
   Hooda Y, Tanmoy AM, Sajib MSI, Saha S. · · 2020 · cited 22× · PMID 32522739 · DOI 10.1136/bmjgh-2020-002446
3. Harmonization of maternal balanced energy-protein supplementation studies for individual participant data (IPD) meta-analyses - finding and creating similarities in variables and data collection.
   Gernand AD, Gallagher K, Bhandari N, Kolsteren P, et al · · 2023 · cited 14× · PMID 36774497 · DOI 10.1186/s12884-023-05366-2
4. Nutritional support for lactating women with or without azithromycin for infants compared to breastfeeding counseling alone in improving the 6-month growth outcomes among infants of peri-urban slums in Karachi, Pakistan-the protocol for a multiarm assessor-blinded randomized cont
   Muhammad A, Shafiq Y, Nisar MI, Baloch B, et al · · 2020 · cited 13× · PMID 32873314 · DOI 10.1186/s13063-020-04662-y
5. Protocol: the International Milk Composition (IMiC) Consortium - a harmonized secondary analysis of human milk from four studies.
   Fehr K, Mertens A, Shu CH, Dailey-Chwalibóg T, et al · · 2025 · cited 4× · PMID 40557242 · DOI 10.3389/fnut.2025.1548739
6. Effect of maternal postnatal balanced energy protein supplementation and infant azithromycin on infant growth outcomes: an open-label randomized controlled trial.
   Muhammad A, Shafiq Y, Nisar MI, Baloch B, et al · · 2024 · cited 4× · PMID 38925354 · DOI 10.1016/j.ajcnut.2024.06.008
7. Effect of one prophylactic dose of azithromycin on Bifidobacterium infantis colonization in infants from the Mumta trial.
   Pasha A, Iqbal NT, Shafiq Y, Khan W, et al · · 2025 · cited 3× · PMID 39855335 · DOI 10.1016/j.ijid.2025.107794
8. Nutritional support for lactating women with or without Azithromycin for infants compared to breast-feeding counselling alone, to improve six-month growth outcomes among infants of peri-urban slums of Karachi, Pakistan – a protocol of multi-arm assessor blinded randomised control
   Muhammad A, Shafiq Y, Nisar MI, Baloch B, et al · · 2020 · DOI 10.21203/rs.3.rs-24814/v3