Nutritional Support and Prophylaxis Doses of Azithromycin for Pregnant Women - Mumta Pregnant Women Trial

NCT04012177 | Unknown DMC

• 1 other identifier: 004-VPT-IRB-18
• Study Type: interventional
• Target: 1,884
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Undernutrition

Outcome Measures

Primary Outcomes (1)

• Birth weight of newborn

  Weight of the newborn assess in gram to assess the difference among four arms

  To be assessed within 72 hours of birth

Secondary Outcomes (1)

• Birth length of newborn

  To be assessed within 72 hours of birth

Other Outcomes (24)

• Maternal hemoglobin

  At enrollment and 32 weeks of pregnancy

• Maternal Ferritin level

  At enrollment and 32 weeks of pregnancy

• Maternal Vitamin D level

  At enrolment and 32 weeks of pregnancy

Study Arms (4)

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)

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).

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).

Dietary Supplement: Balanced-energy protein (BEP); Drug: Azithromycin Tablets; Drug: Choline Bitartrate; Drug: Nicotinamide

Interventions

Balanced-energy protein (BEP) DIETARY_SUPPLEMENT

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.

Also known as: Ready-to-use-supplementary food (RUSF)

Nutrition only Arm; Nutrition plus Azithromycin Arm; Nutrition plus Choline and Nicotinamide Arm

Azithromycin Tablets DRUG

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.

Also known as: Zetro

Nutrition plus Azithromycin Arm; Nutrition plus Choline and Nicotinamide Arm

Choline Bitartrate DRUG

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

Also known as: Choline

Nutrition plus Choline and Nicotinamide Arm

Nicotinamide DRUG

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

Nutrition plus Choline and Nicotinamide Arm

Eligibility Criteria

• Age: 13 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Having Mid-upper-arm-circumference of pregnant of ≥30.5 cm
• Having known food allergies if reported by woman (like peanut, lentils)

Sponsors & Collaborators

• Vital Pakistan Trust: lead
• Aga Khan University: collaborator

Study Sites (1)

Peri-urban slum (Rehri Goth)

Karachi, Sindh, Pakistan

Location

Related Publications (1)

• Muhammad 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.

  PMID: 34980232 DERIVED

MeSH Terms

Conditions

Malnutrition

Interventions

Azithromycin; Choline; Niacinamide

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Ethanolamines; Amino Alcohols; Alcohols; Amines; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Yasir Shafiq, MSc

  Vital Pakistan Trust

  PRINCIPAL INVESTIGATOR

• Ameer Muhammad, MSc

  Vital Pakistan Trust

  PRINCIPAL INVESTIGATOR

• Fyezah Jehan, MSc

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Muhammad Imran Nisar, MSc

  Aga Khan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Manager, Research and Programs

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 9, 2019
• Study Start: July 22, 2019
• Primary Completion: September 5, 2022
• Study Completion: December 31, 2023
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)