An interventional study of Balanced energy-protein (BEP) and Azithromycin in Undernutrition, sponsored by Vital Pakistan Trust. Completed at 1 site in Pakistan. Open to female participants aged 13 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-26.
Sponsored by Vital Pakistan Trust · Not applicable, Interventional, and Treatment
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.
1,587 studies on the registry are indexed under Malnutrition; 237 are open to participants now.
This study's enrollment of 957 is above the median of 90 across 1,134 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →Vital Pakistan Trust is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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.
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)
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) · Drug: Azithromycin
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.
Also known as: RUSF
A single prophylaxis dose of 20 mg/kg in suspension form, reconstituted by trial staff before dose administration by the same.
Also known as: Suspension
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
Time frame: 6 months of infant age, after birth and enrollment through monthly assessment
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months of infant age, after birth and enrollment through monthly assessment
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At day 40-42 and 56 of infant age
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Vital Pakistan Trust