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| Name | Class |
|---|---|
| Aga Khan University | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | No Intervention | 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. | |
| Arm B | Experimental | 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. |
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| Arm C | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balanced energy-protein (BEP) | Dietary Supplement | 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Lactating women
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| Name | Affiliation | Role |
|---|---|---|
| Yasir Shafiq, MSc | Vital Pakistan Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peri-urban slums of Karachi (Rehri Goth, Bhains Colony and Ali Akber Shah Goth) | Karachi | Sindh | 75300 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38925354 | Derived | Muhammad A, Shafiq Y, Nisar MI, Baloch B, Pasha A, Yazdani NS, Rizvi A, Muhammad S, Jehan F. Effect of maternal postnatal balanced energy protein supplementation and infant azithromycin on infant growth outcomes: an open-label randomized controlled trial. Am J Clin Nutr. 2024 Sep;120(3):550-559. doi: 10.1016/j.ajcnut.2024.06.008. Epub 2024 Jun 24. | |
| 32873314 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 27, 2020 | Jan 12, 2021 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 16, 2019 | Jan 23, 2021 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| D013535 | Suspensions |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Azithromycin | Drug | A single prophylaxis dose of 20 mg/kg in suspension form, reconstituted by trial staff before dose administration by the same. |
|
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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 |
| 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 |
| 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. |
| Organic Chemicals |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |