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

Nutritional Support for Lactating Women and Azithromycin to Infants to Improve Growth Outcomes in Peri-urban Slums of Karachi, Pakistan - Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Undernutrition
• Intervention / Treatment: Dietary supplement: Balanced energy-protein (BEP); Drug: Azithromycin

• Study Type: Interventional
• Enrollment (Actual): 957
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75300
      • Peri-urban slums of Karachi (Rehri Goth, Bhains Colony and Ali Akber Shah Goth)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Mid-upper-arm-circumference of lactating women less than 23.0 cm, whose birth outcome should be captured within 168 hours
• Singleton alive baby
• Intention to stay in the catchment area for the entire duration of the trial after enrolment
• Intention to breastfeed the child for at least 6 months
• Voluntary written consent

Exclusion Criteria:

• Weight of newborn at first assessment, within 168 hours of birth is less than 1500 gm
• Newborn with known congenital anomaly or sign of serious illness based of study physician's assessment before enrollment.
• Lactating women has known allergies to peanut, lentils, chickpea or dairy products.
• Lactating woman who have some serious medical illness/condition due to which she is not able to or not willing to breastfeed the child, like breast cancer, inverted nipples.
• Previous enrolment in the same trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Arm A; Control arm: Lactating women (LW) randomized in this arm will only receive standard of care which comprises of standard nutritional counseling, key messages of exclusive breastfeeding, essential newborn and infant care and immunization.
Experimental: Arm B; Intervention arm B: Lactating women (LW) randomized in this arm will receive ready-to-use nutritional supplement, 'Balanced energy-protein (BEP)' 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.	Dietary supplement: Balanced energy-protein (BEP); 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.; Other Names: RUSF
Experimental: Arm C; Intervention arm B: Lactating women (LW) randomized in this arm will receive ready-to-use nutritional supplement, 'Balanced energy-protein (BEP)' for next 6 months to be consumed in a dose of 2 sachets of 75 grams per day. Further, the same 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.	Dietary supplement: Balanced energy-protein (BEP); 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.; Other Names: RUSF; Drug: Azithromycin; A single prophylaxis dose of 20 mg/kg in suspension form, reconstituted by trial staff before dose administration by the same.; Other Names: Suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length velocity at 6 months of infant's age	Mean difference in length velocity of >0.12 cm /month to look at comparisons between multiple arms	6 months of infant age, after birth and enrollment through monthly assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth velocity at 6 months of infant's age	Mean difference in growth velocity of >0.4 gram/kg/day to look at comparisons between multiple arms	6 months of infant age, after birth and enrollment through monthly assessment
Length-for-Age Z-score (LAZ) of infants at 6 months of age	Mean difference in LAZ >0.5 to look at comparisons between multiple arms	6 months of infant age, after birth and enrollment through monthly assessment
Weight-for-Length Z-score (WLZ) of infants at 6 months of age	Mean difference in WLZ of >0.5 to look at comparisons between multiple arms	6 months of infant age, after birth and enrollment through monthly assessment
Weight-for-Age Z-score of (WAZ) infants at 6 months of age	Mean difference in WAZ of >0.5 to look at comparisons between multiple arms	6 months of infant age, after birth and enrollment through monthly assessment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast milk composition	50 systematically selected lactating women in each arm will be approached for breast milk specimen to assess quality of breast milk composition (macro- and micro-nutrients), Human Milk Oligosaccharides (HMO), immunoglobulins and microbiome analysis. Same 50 women will be selected for outcome 7 and 8	breast milk specimens will be collected at day 40-42 and 56 of infant age
Stool specimens of lactating women and infants	Same 50 systematically selected lactating women in each arm will also be approached for stool samples on the same day and stool from the same infant will also be collected. Stool will be collected for TaqMan Array Card (TAC) analysis of enteric pathogens, B. Infantis, Calprotectin, Lipocalin 2 and Myeloperoxidase (MPO) as a marker of gut inflammation and will be assessed using a metagenomic approach	At day 40-42 and 56 of infant age
Blood specimens of lactating women	Same 50 systematically selected lactating women in each arm will be approached for blood specimens to assess haemoglobin, serum Ferritin, Transferrin receptor and Acute phase proteins such as AGP and CRP	At day 40-42 and 56 of infant age
Blood specimens of infants	All infants will be approached for blood speciemens to assess haemoglobin, serum Ferritin, Transferrin receptor, plasma proteomics and Acute phase proteins such as AGP and CRP	At day 40-42 and 56 of infant age

Collaborators and Investigators

• Sponsor: Vital Pakistan Trust
• Collaborators: Aga Khan University
• Investigators: Principal Investigator: Yasir Shafiq, MSc, Vital Pakistan Trust

Publications and helpful links

General Publications

• Muhammad A, Shafiq Y, Nisar MI, Baloch B, Yazdani AT, Yazdani N, Jehan F. 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 controlled trial (Mumta LW trial). Trials. 2020 Sep 1;21(1):756. doi: 10.1186/s13063-020-04662-y.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): November 20, 2020
• Study Completion (Actual): November 20, 2020

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 11, 2018
• First Posted (Actual): June 21, 2018

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 23, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Anti-Infective Agents; Anti-Bacterial Agents; Azithromycin
• Other Study ID Numbers: 002-VPT-IRB-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No