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

• ClinicalTrials.gov Identifier: NCT03564652
• Recruitment Status: Completed
• First Posted: June 21, 2018
• Last Update Posted: January 26, 2021
• Sponsor: Vital Pakistan Trust
• Collaborator: Aga Khan University
• Information provided by (Responsible Party): Yasir Shafiq, Vital Pakistan Trust

Tracking Information

• First Submitted Date: June 11, 2018
• First Posted Date: June 21, 2018
• Last Update Posted Date: January 26, 2021
• Actual Study Start Date: August 1, 2018
• Actual Primary Completion Date: November 20, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 11, 2018)

Length velocity at 6 months of infant's age [ Time Frame: 6 months of infant age, after birth and enrollment through monthly assessment ]

Mean difference in length velocity of >0.12 cm /month to look at comparisons between multiple arms

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 11, 2018)

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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: March 28, 2020)

• Breast milk composition [ Time Frame: breast milk specimens will be collected at day 40-42 and 56 of infant age ]
  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
• Stool specimens of lactating women and infants [ Time Frame: At day 40-42 and 56 of infant age ]
  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
• Blood specimens of lactating women [ Time Frame: At day 40-42 and 56 of infant age ]
  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
• Blood specimens of infants [ Time Frame: At day 40-42 and 56 of infant age ]
  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

Original Other Pre-specified Outcome Measures (submitted: June 11, 2018)

• Breast milk composition [ Time Frame: breast milk specimens will be collected at day 28 and 120 of infant age ]
  50 randomly selected lactating women in each arm will be approached for breast milk specimen to assess quality of breast milk (macro- and micro-nutrients) and microbiome analysis. Same 50 women will be selected for outcome 7 and 8
• Stool specimens of lactating women and infants [ Time Frame: At day 28 and 120 of infant age ]
  Same 50 randomly 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 and Myeloperoxidase (MPO) as a marker of gut inflammation and will be assessed using a metagenomic approach
• Blood specimens of lactating women [ Time Frame: At day 28 and 120 of infant age ]
  Same 50 randomly 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
• Blood specimens of infants [ Time Frame: At day 28 and 120 of infant age ]
  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

Descriptive Information

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

Brief 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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Undernutrition

Intervention

• 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 Name: 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 Name: Suspension

Study Arms

• 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.
  Intervention: Dietary Supplement: Balanced energy-protein (BEP)
• 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.
  Interventions:

  • Dietary Supplement: Balanced energy-protein (BEP)
  • Drug: Azithromycin

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 11, 2018): 957
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 20, 2020
• Actual Primary Completion Date: November 20, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Lactating women

• Ages: 13 Years to 49 Years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Pakistan

Administrative Information

• NCT Number: NCT03564652
• Other Study ID Numbers: 002-VPT-IRB-18
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Yasir Shafiq, Vital Pakistan Trust
• Original Responsible Party: Same as current
• Current Study Sponsor: Vital Pakistan Trust
• Original Study Sponsor: Same as current
• Collaborators: Aga Khan University

Investigators

• Principal Investigator: Yasir Shafiq, MSc; Vital Pakistan Trust

• PRS Account: Vital Pakistan Trust
• Verification Date: January 2021