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

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ClinicalTrials.gov Identifier: NCT03564652
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : November 20, 2018
Sponsor:
Collaborator:
Aga Khan University
Information provided by (Responsible Party):
Yasir Shafiq, Vital Pakistan Trust

Brief Summary:

A community-based, randomized control, assessor blinded trial in peri-urban settings of Karachi, Pakistan to study the impact of LNS PLW (Lipid-based Nutritional Supplement for Pregnant and Lactating women) which is balanced energy-protein 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 72 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 LNS PLW 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.


Condition or disease Intervention/treatment Phase
Undernutrition Dietary Supplement: LNS PLW Drug: Azithromycin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 957 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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, 'LNS PLW' 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: LNS PLW
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

Experimental: Arm C
Intervention arm B: Lactating women (LW) randomized in this arm will receive ready-to-use nutritional supplement, 'LNS PLW' 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: LNS PLW
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Other Outcome Measures:
  1. Breast milk composition [ Time Frame: breast milk specimens will be collected at day 40-42 and 56 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

  2. Stool specimens of lactating women and infants [ Time Frame: At day 40-42 and 56 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

  3. Blood specimens of lactating women [ Time Frame: At day 40-42 and 56 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

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Lactating women
Accepts Healthy Volunteers:   Yes
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 enrollment
  • Intention to breastfeed the child for at least 6 months
  • Voluntary written consent

Exclusion Criteria:

  • Birth weight of newborn is less than 1500 gm
  • Newborn with known congenital anomaly or sign of serious illness based of study physcian's assessment before enrollment.
  • Lactating women has known allergies to peanut, lentils, chickpea or dairy products.
  • Previous enrollment in the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564652


Contacts
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Contact: Yasir Shafiq, MSc +922134974544 yasir.shafiq@vitalpakistantrust.org
Contact: Amna Tanweer Yazdani, MSc +922134974544 amna.yazdani@vitalpakistantrust.org

Locations
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Pakistan
Peri-urban slums of Karachi (Rehri Goth, Bhains Colony and Ali Akber Shah Goth) Recruiting
Karachi, Sindh, Pakistan, 75300
Contact: Yasir Shafiq, Master    +922134974544    yasir.shafiq@vitalpakistantrust.org   
Contact: Amna Tanweer Yazdani, Master    +922134974544    amna.yazdani@vitalpakistantrust.org   
Principal Investigator: Yasir Shafiq, MSc         
Sub-Investigator: Amna Tanweer Yazdani, MSc         
Sub-Investigator: Fyezah Jehan, MSc         
Sub-Investigator: Muhammad Imran Nisar, MSc         
Sponsors and Collaborators
Vital Pakistan Trust
Aga Khan University
Investigators
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Principal Investigator: Yasir Shafiq, MSc Vital Pakistan Trust

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Responsible Party: Yasir Shafiq, Research Manager, Vital Pakistan Trust
ClinicalTrials.gov Identifier: NCT03564652     History of Changes
Other Study ID Numbers: 002-VPT-IRB-18
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders