UndernutritionMumtaPWNCT04012177
Nutritional Support and Prophylaxis Doses of Azithromycin for Pregnant Women - Mumta Pregnant Women Trial
A study testing Balanced-energy protein (BEP), Azithromycin Tablets and Choline Bitartrate in people with Undernutrition, run by Vital Pakistan Trust at 1 site in Pakistan.
Trial summary
This four arm trial envisions to generate robust evidence for use of a fortified balanced energy-protein supplement to pregnant women for at least 6 months, alone versus in combination of Azithromycin (AZM) prophylaxis (two prophylaxis oral doses) versus in combination with both AZM prophylaxis (two prophylaxis oral… 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), Azithromycin Tablets and Choline Bitartrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,884 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Jul 2019to 31 Dec 2023
- 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
- Gestational age between ≥8 and < 19 weeks confirmed by ultrasound
- Able to give written voluntary informed consent.
- Permanent resident within the surveillance area, i.e. woman should be resident of the area for last 6 months at least to be considered as part of surveillance.
- Willing to spend the whole pregnancy duration after registration in trial within surveillance area until the birth outcome.
- Singleton and viable fetus on ultrasound
- Not working woman, and available for ANC and compliance visits at home.
- Previously not enrolled in pregnant woman trial.
- Previously not enrolled in Lactating woman trials.
Who cannot join
- Having Mid-upper-arm-circumference of pregnant of ≥30.5 cm
- Having known food allergies if reported by woman (like peanut, lentils)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nutritional Support and Prophylaxis Doses of Azithromycin for Pregnant Women to Improve Birth Outcomes in the Peri-urban Slums of Karachi, Pakistan -a Randomized Controlled Trial
This four arm trial envisions to generate robust evidence for use of a fortified balanced energy-protein supplement to pregnant women for at least 6 months, alone versus in combination of Azithromycin (AZM) prophylaxis (two prophylaxis oral doses) versus in combination with both AZM prophylaxis (two prophylaxis oral doses) plus oral Choline and Nicotinamide supplementation; to see the impact on birth weight and length of newborn soon after birth (approximately within 72 hours). This is an open label, community-based, randomized controlled trial in peri-urban settings of Karachi, Pakistan, where the outcome assessor will be blinded. The comparison groups are control arm (only routine ANC care and nutritional counseling), nutrition only arm, nutrition plus AZM arm, and nutrition plus Choline and Nicotinamide arm.
Read the detailed description
Maternal under nutrition has a critical role in etiology of poor perinatal outcomes like low birth weight (LBW), accounting for 60-80% of all neonatal deaths and impacting nearly 20 million newborns overall. In Pakistan, nearly half of the households are food insecure with or without hunger. Great disparities exist between urban-rural and within urban disadvantaged populations living in the poorest of slums. In Sindh province alone, 72% of households are food insecure and 50% are with moderate to severe hunger. Around 18% of the married woman of reproductive age in Pakistan, are underweight and deficient of different micronutrients for example, 42% and 41% of women are Vitamin A and Zinc deficient, respectively.. This impacts childhood stunting, wasting, and underweight, prevalence of which, among under-five children is around 44%, 15% and 31%, respectively in Pakistan. WHO antenatal care (ANC) guidelines recommend the use of fortified balanced energy-protein supplements during pregnancy, but there is a lack of guidance on the best product/supplement for use in a particular setting. Until recently, the WHO ANC guidelines has made no recommendations on the use of these supplements in food insecure and undernourished settings. This is an area that required further research. Additionally, there is emerging literature on use of Choline and Nicotinamide during pregnancy and its potential additional impact on birth outcomes including growth and development after prenatal supplementation with Choline and Nicotinamide.
Apart from nutrition supplement, the prophylaxis use of antibiotics, especially AZM is also under strong debate, as many studies have shown improvements in birth outcomes in low middle income settings. The possible mechanism of AZM may be explained through reduction in the risk of maternal infections during pregnancy. A systematic review showed that prophylaxis may reduce the risk of postpartum endometritis, preterm rupture of membranes and gonococcal infection when given routinely to all pregnant women With no effect on birth outcome but there were several biases reported such as high loss to follow-ups and limited numbers of included studies.. Therefore, robust evidence is needed via a field trial in the local context to evaluate the efficacy and effectiveness of the locally-produced, balanced energy-protein supplement alone or in combination with prophylaxis dose of AZM or balanced energy-protein supplement alone or in combination with Choline and Nicotinamide to pregnant woman on maternal and birth outcomes in low-income and food insecure settings. This could help to draw inferences for larger public health policy-making. This investment is specifically aiming to look at what impact a newly formulated nutritional supplement for pregnant and lactating women (PLW) can have on improving birth outcomes and as well as its potential to reduce wasting, stunting and underweight in infants.
- Conditions
- Undernutrition
- Being tested
- Balanced-energy protein (BEP), Azithromycin Tablets, Choline Bitartrate, Nicotinamide
- 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 Ready-to-use-supplementary food (RUSF)
Pregnant 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.
Azithromycin TabletsDrug
Also called Zetro
Pregnant women randomized in Arm C will received two doses of 2000 mg of Azithromycin (4 tablets of 500 mg) oral at week 20 and 28 of pregnancy.
Choline BitartrateDrug
Also called Choline
Pregnant women randomized in Arm D will received 450 mg of Choline orally once daily, starting from week 20 weeks of pregnancy until birth outcome
NicotinamideDrug
Pregnant women randomized in Arm D will received 100 mg of Nicotinamide orally once daily, starting from week 20 weeks of pregnancy until birth outcome
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Arm-A: Standard antenatal care (ANC) counseling, service provision and nutrition counseling (World Health Organization (WHO) standard) |
| Nutrition only Arm | Experimental | Arm-B:Balanced-energy protein (BEP), ready-to-use utrition supplement for at least 6 months + Standard ANC counseling, service provision and nutrition counseling (WHO standard) Receives: Dietary Supplement: Balanced-energy protein (BEP) |
| Nutrition plus Azithromycin Arm | Experimental | Arm-C:Balanced-energy protein (BEP), ready-to-use nutrition supplement for at least 6 months + 2000 mg of Azithromycin at week 20 and 28 of pregnancy + Standard ANC counseling, service provision and nutrition counseling (WHO standard). Receives: Dietary Supplement: Balanced-energy protein (BEP); Drug: Azithromycin Tablets |
| Nutrition plus Choline and Nicotinamide Arm | Experimental | Arm-D: Balanced-energy protein (BEP), ready-to-use nutrition supplement for at least 6 months + Choline 450 and Nicotinamide 100 mg (1 each once daily orally starting from week 20 until birth outcome) + Standard ANC counseling, service provision and nutrition counseling (WHO standard). Receives: Dietary Supplement: Balanced-energy protein (BEP); Drug: Azithromycin Tablets; Drug: Choline Bitartrate; Drug: Nicotinamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth weight of newborn
Weight of the newborn assess in gram to assess the difference among four arms
Measured: To be assessed within 72 hours of birth
Secondary outcomes (1)
Birth length of newborn
Length of the newborn assess in cm to assess the difference among four arms
Measured: To be assessed within 72 hours of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2019
- Study start22 Jul 2019
- Primary completion5 Sep 2022
- Study completion31 Dec 2023 (estimated)
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
- 1,884 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 TrustAmeer Muhammad, MSc, Principal investigator, Vital Pakistan TrustFyezah Jehan, MSc, Principal investigator, Aga Khan UniversityMuhammad Imran Nisar, MSc, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04012177
- Sponsor's protocol ID
- 004-VPT-IRB-18
- Acronym
- MumtaPW
- Status last verified
- Oct 2022
- First submitted
- 1 Jul 2019
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pasha A, Khan S, Qazi MF, Balouch B, Qamar JB, Nisar MI, Jehan F. Impact of Prenatal Nutrition Interventions on Infant Longitudinal Growth: A Secondary Analysis of the Mumta Pregnant Women Trial in Pakistan. Mayo Clin Proc Innov Qual Outcomes. 2026 Jun 30;10(4):100727. doi: 10.1016/j.mayocpiqo.2026.100727. eCollection 2026 Aug.
PubMed 42421698Muhammad A, Fazal ZZ, Baloch B, Nisar I, Jehan F, Shafiq Y. Nutritional support and prophylaxis of azithromycin for pregnant women to improve birth outcomes in peri-urban slums of Karachi, Pakistan-a protocol of multi-arm assessor-blinded randomized controlled trial (Mumta PW trial). Trials. 2022 Jan 3;23(1):2. doi: 10.1186/s13063-021-05960-9.
PubMed 34980232
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Support and Prophylaxis Doses of Azithromycin for Pregnant Women to Improve Birth Outcomes in the Peri-urban Slums of Karachi, Pakistan -a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04012177
- Acronym / sponsor ID
- MumtaPW / 004-VPT-IRB-18
- Conditions
- Undernutrition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,884 participants (actual)
- Lead sponsor
- Vital Pakistan TrustUniversity, hospital or other
- Collaborators
- Aga Khan University
- Study start
- 22 Jul 2019 (actual)
- Primary completion
- 5 Sep 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 9 Jul 2019 (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.
This four arm trial envisions to generate robust evidence for use of a fortified balanced energy-protein supplement to pregnant women for at least 6 months, alone versus in combination of Azithromycin (AZM) prophylaxis (two prophylaxis oral doses) versus in combination with both AZM prophylaxis (two prophylaxis oral doses) plus oral Choline and Nicotinamide supplementation; to see the impact on birth weight and length of newborn soon after birth (approximately within 72 hours). This is an open label, community-based, randomized controlled trial in peri-urban settings of Karachi, Pakistan, where the outcome assessor will be blinded. The comparison groups are control arm (only routine ANC care and nutritional counseling), nutrition only arm, nutrition plus AZM arm, and nutrition plus Choline and Nicotinamide arm.
Detailed description
Maternal under nutrition has a critical role in etiology of poor perinatal outcomes like low birth weight (LBW), accounting for 60-80% of all neonatal deaths and impacting nearly 20 million newborns overall. In Pakistan, nearly half of the households are food insecure with or without hunger. Great disparities exist between urban-rural and within urban disadvantaged populations living in the poorest of slums. In Sindh province alone, 72% of households are food insecure and 50% are with moderate to severe hunger. Around 18% of the married woman of reproductive age in Pakistan, are underweight and deficient of different micronutrients for example, 42% and 41% of women are Vitamin A and Zinc deficient, respectively.. This impacts childhood stunting, wasting, and underweight, prevalence of which, among under-five children is around 44%, 15% and 31%, respectively in Pakistan. WHO antenatal care (ANC) guidelines recommend the use of fortified balanced energy-protein supplements during pregnancy, but there is a lack of guidance on the best product/supplement for use in a particular setting. Until recently, the WHO ANC guidelines has made no recommendations on the use of these supplements in food insecure and undernourished settings. This is an area that required further research. Additionally, there is emerging literature on use of Choline and Nicotinamide during pregnancy and its potential additional impact on birth outcomes including growth and development after prenatal supplementation with Choline and Nicotinamide.
Apart from nutrition supplement, the prophylaxis use of antibiotics, especially AZM is also under strong debate, as many studies have shown improvements in birth outcomes in low middle income settings. The possible mechanism of AZM may be explained through reduction in the risk of maternal infections during pregnancy. A systematic review showed that prophylaxis may reduce the risk of postpartum endometritis, preterm rupture of membranes and gonococcal infection when given routinely to all pregnant women With no effect on birth outcome but there were several biases reported such as high loss to follow-ups and limited numbers of included studies.. Therefore, robust evidence is needed via a field trial in the local context to evaluate the efficacy and effectiveness of the locally-produced, balanced energy-protein supplement alone or in combination with prophylaxis dose of AZM or balanced energy-protein supplement alone or in combination with Choline and Nicotinamide to pregnant woman on maternal and birth outcomes in low-income and food insecure settings. This could help to draw inferences for larger public health policy-making. This investment is specifically aiming to look at what impact a newly formulated nutritional supplement for pregnant and lactating women (PLW) can have on improving birth outcomes and as well as its potential to reduce wasting, stunting and underweight in infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | –Arm-A: Standard antenatal care (ANC) counseling, service provision and nutrition counseling (World Health Organization (WHO) standard) |
| Nutrition only Arm | Experimental | Dietary Supplement: Balanced-energy protein (BEP)Arm-B:Balanced-energy protein (BEP), ready-to-use utrition supplement for at least 6 months + Standard ANC counseling, service provision and nutrition counseling (WHO standard) |
| Nutrition plus Azithromycin Arm | Experimental | Dietary Supplement: Balanced-energy protein (BEP), Drug: Azithromycin TabletsArm-C:Balanced-energy protein (BEP), ready-to-use nutrition supplement for at least 6 months + 2000 mg of Azithromycin at week 20 and 28 of pregnancy + Standard ANC counseling, service provision and nutrition counseling (WHO standard). |
| Nutrition plus Choline and Nicotinamide Arm | Experimental | Dietary Supplement: Balanced-energy protein (BEP), Drug: Azithromycin Tablets, Drug: Choline Bitartrate, Drug: NicotinamideArm-D: Balanced-energy protein (BEP), ready-to-use nutrition supplement for at least 6 months + Choline 450 and Nicotinamide 100 mg (1 each once daily orally starting from week 20 until birth outcome) + Standard ANC counseling, service provision and nutrition counseling (WHO standard). |
Who may qualify
- Ages
- 13 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Gestational age between ≥8 and < 19 weeks confirmed by ultrasound
- Able to give written voluntary informed consent.
- Permanent resident within the surveillance area, i.e. woman should be resident of the area for last 6 months at least to be considered as part of surveillance.
- Willing to spend the whole pregnancy duration after registration in trial within surveillance area until the birth outcome.
- Singleton and viable fetus on ultrasound
Key exclusion criteria (2 listed)
- Having Mid-upper-arm-circumference of pregnant of ≥30.5 cm
- Having known food allergies if reported by woman (like peanut, lentils)
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: Ready-to-use-supplementary food (RUSF)Pregnant 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 | Nutrition only Arm, Nutrition plus Azithromycin Arm, Nutrition plus Choline and Nicotinamide Arm |
| Azithromycin TabletsAlso: ZetroPregnant women randomized in Arm C will received two doses of 2000 mg of Azithromycin (4 tablets of 500 mg) oral at week 20 and 28 of pregnancy. | Drug | Nutrition plus Azithromycin Arm, Nutrition plus Choline and Nicotinamide Arm |
| Choline BitartrateAlso: CholinePregnant women randomized in Arm D will received 450 mg of Choline orally once daily, starting from week 20 weeks of pregnancy until birth outcome | Drug | Nutrition plus Choline and Nicotinamide Arm |
| NicotinamidePregnant women randomized in Arm D will received 100 mg of Nicotinamide orally once daily, starting from week 20 weeks of pregnancy until birth outcome | Drug | Nutrition plus Choline and Nicotinamide Arm |
Primary outcome
Birth weight of newborn
Time frame: To be assessed within 72 hours of birth
Weight of the newborn assess in gram to assess the difference among four arms
1 secondary outcome
Birth length of newborn
Time frame: To be assessed within 72 hours of birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Derived from this study: PubMed 42421698Pasha A, Khan S, Qazi MF, Balouch B, Qamar JB, Nisar MI, Jehan F. Impact of Prenatal Nutrition Interventions on Infant Longitudinal Growth: A Secondary Analysis of the Mumta Pregnant Women Trial in Pakistan. Mayo Clin Proc Innov Qual Outcomes. 2026 Jun 30;10(4):100727. doi: 10.1016/j.mayocpiqo.2026.100727. eCollection 2026 Aug.
- Derived from this study: PubMed 34980232Muhammad A, Fazal ZZ, Baloch B, Nisar I, Jehan F, Shafiq Y. Nutritional support and prophylaxis of azithromycin for pregnant women to improve birth outcomes in peri-urban slums of Karachi, Pakistan-a protocol of multi-arm assessor-blinded randomized controlled trial (Mumta PW trial). Trials. 2022 Jan 3;23(1):2. doi: 10.1186/s13063-021-05960-9.
- Individual participant dataSharing planned: No
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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
Ameer Muhammad, MSc principal investigator
Vital Pakistan Trust
Fyezah Jehan, MSc principal investigator
Aga Khan University
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), Azithromycin Tablets and Choline Bitartrate 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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Oct 2022. 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?
Results are not available in the source record.
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?
Birth weight of newborn (time frame: To be assessed within 72 hours of birth). 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 NCT04012177, 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 13 Oct 2022.