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

NCT04012177 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1884

Last updated 2022-10-13

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Balanced-energy protein (BEP)

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.

DRUG

Azithromycin Tablets

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.

DRUG

Choline Bitartrate

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

DRUG

Nicotinamide

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

Sponsors & Collaborators

  • Aga Khan University

    collaborator OTHER

  • Vital Pakistan Trust

    lead OTHER

Principal Investigators

  • Yasir Shafiq, MSc · Vital Pakistan Trust

  • Ameer Muhammad, MSc · Vital Pakistan Trust

  • Fyezah Jehan, MSc · Aga Khan University

  • Muhammad Imran Nisar, MSc · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-22
Primary Completion
2022-09-05
Completion
2023-12-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04012177 on ClinicalTrials.gov