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Effect of Energy Dense Biscuits in Undernourished Women on Birth Weight of Their Neonates

NCT02294240 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2016-01-11

No results posted yet for this study

Summary

A nutrition trial which is based on the evidence that multivitamins \& micro nutrients provided during pregnancy in malnourished women will improve neonatal birth weight. There will be two arms. Arm one will provide energy dense biscuits to pregnant women with BMI \<20 \& gestational age less than 14 weeks. The other arm with same criteria will be provided with wheat flour, oil, iron \& folic acid. Neonatal birth weight is the primary outcome of interest but maternal weight gain, maternal hemoglobin \& ferritin levels and palatability of biscuits will also be assessed.

Conditions

  • Birth Weight

Interventions

DIETARY_SUPPLEMENT

Energy dense biscuits

Energy dense biscuits will be provided

OTHER

Wheat Flour, oil, iron & Folic acid

Wheat flour, oil, iron and folic acid will be provided

Sponsors & Collaborators

  • English Biscuit Manufacturers

    collaborator UNKNOWN

  • Aga Khan University

    lead OTHER

Principal Investigators

  • Farah N Qamar · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-01-31
Completion
2016-03-31

Countries

  • Pakistan

Study Locations

More Related Trials

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 NCT02294240 on ClinicalTrials.gov