UndernutritionMumtaLWNCT03564652
Nutritional Support for Lactating Women and Azithromycin to Infants - Mumta Lactating Women Trial
A study testing Balanced energy-protein (BEP) and Azithromycin in people with Undernutrition, run by Vital Pakistan Trust at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Undernutrition
- What is being tested?
- Balanced energy-protein (BEP) and Azithromycin
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 957 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2018to 20 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Peri-urban slums of Karachi (Rehri Goth, Bhains Colony and Ali Akber Shah Goth)
Karachi, Sindh, 75300
About this study
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
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:
- 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.
- 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.
- 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.
Read more
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.
- Conditions
- Undernutrition
- Being tested
- Balanced energy-protein (BEP), Azithromycin
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balanced energy-protein (BEP)Dietary supplement
Also called RUSF
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.
AzithromycinDrug
Also called Suspension
A single prophylaxis dose of 20 mg/kg in suspension form, reconstituted by trial staff before dose administration by the same.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Balanced energy-protein (BEP) |
| 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. Receives: Dietary Supplement: Balanced energy-protein (BEP); Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months of infant age, after birth and enrollment through monthly assessment
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 months of infant age, after birth and enrollment through monthly assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start1 Aug 2018
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for UndernutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 957 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vital Pakistan Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan University
- Responsible party
- Principal investigator, Yasir Shafiq, Vital Pakistan Trust
- Investigators
- Yasir Shafiq, MSc, Principal investigator, Vital Pakistan Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564652
- Sponsor's protocol ID
- 002-VPT-IRB-18
- Acronym
- MumtaLW
- Status last verified
- Jan 2021
- First submitted
- 11 Jun 2018
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38925354Muhammad 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.
PubMed 32873314
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03564652
- Acronym / sponsor ID
- MumtaLW / 002-VPT-IRB-18
- Conditions
- Undernutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 957 participants (actual)
- Lead sponsor
- Vital Pakistan TrustUniversity, hospital or other
- Collaborators
- Aga Khan University
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | 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, 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. |
| Arm C | Experimental | Dietary Supplement: Balanced energy-protein (BEP), Drug: AzithromycinIntervention 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. |
Who may qualify
- Ages
- 13 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balanced energy-protein (BEP)Also: RUSFLactating 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. | Dietary supplement | Arm B, Arm C |
| AzithromycinAlso: SuspensionA single prophylaxis dose of 20 mg/kg in suspension form, reconstituted by trial staff before dose administration by the same. | Drug | Arm C |
Primary outcome
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
4 secondary outcomes
Growth velocity at 6 months of infant's age
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
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
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
Time frame: 6 months of infant age, after birth and enrollment through monthly assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Derived from this study: PubMed 38925354Muhammad 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.
- Derived from this study: PubMed 32873314Muhammad 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasir Shafiq, MSc principal investigator
Vital Pakistan Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balanced energy-protein (BEP) and Azithromycin in people with Undernutrition, run by Vital Pakistan Trust at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length velocity at 6 months of infant's age (time frame: 6 months of infant age, after birth and enrollment through monthly assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03564652, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.