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

January 7, 2016 updated by: Dr Faraz Naz Qamar, Aga Khan University

Effect of Energy Dense Biscuits in Under Nourished Pregnant Women on Birth Weight of Their Newborns in a Low Income Peri-urban Setting of Karachi; a Community Based Randomized Interventional Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

It has been realized that micronutrient deficiencies are a major determinant of intra-uterine growth retardation (IUGR) so multiple trials using micronutrient supplementation during pregnancy have been done & shown a positive effect on birth weight.UNICEF/WHO/United Nations University(UNU) designed a new multiple micro nutrient supplement for pregnant and lactating women-the UNICEF/WHO/UNU international multiple micro nutrient preparation (UNIMMAP)-that provides the Recommended Dietary Allowance (RDA) of 15 vitamins and minerals. The benefit of this supplementation over routinely prescribed iron and folic supplementation has been proven in multiple trials. Evidence has shown reduction in low birth newborns.

This randomized controlled trial will compare the effect of calories and multiple micro nutrients provided in energy dense biscuits manufactured by EBM to malnourished pregnant women seen by AKU's Department of Paediatrics and Child Health at their Ali Akbar Shah Goth and Ibrahim Hyderi, compared to food supplementation ration of wheat and oil, plus iron and folic acid tablet supplementation.

Arm 1: Dietary supplementation with EBM biscuits containing multiple vitamins and calcium in the recommended allowance (RDA) for pregnant women Arm 2: Supplementation with Wheat flour and oil, iron and folic acid All undernourished pregnant females identified before 14 weeks of gestation through our surveillance system will be offered enrollment.

First contact: First meeting will be on enrollment. Patients will be randomized into any one of the arm. After randomization Weight, height, MUAC and BMI will be recorded. Samples for Ferritin & hemoglobin will be drawn. In Arm 1 participant will be supplied with energy dense biscuits while in arm 2 will be provided with Wheat flour and oil after every two weeks.

End of each trimester: In second(20-22 week) & third trimester(33-35 week) weight, MUAC & BMI will be recorded. Supplementation will be given according to the Arm. Samples will also be drawn for Ferritin & hemoglobin on third visit. Also at the third trimester visit palatability, accessibility and compliance with biscuits will be assessed by filling a preformed questionnaire.

Follow up of the newborn: Follow up of the newborn will be done within 48 hours. Length, weight, fronto-occipital circumference and MUAC will be recorded.

Study Type

Interventional

Enrollment (Anticipated)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • Ali Akbar Shah
      • Karachi, Sindh, Pakistan
        • Ibrahim Hyderi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

All pregnant females with gestational age ≤14 weeks and Body mass index(BMI) <18.5

Exclusion Criteria:

Pregnant females with underlying chronic illness (cardiovascular disease, diabetes, renal disease, and hypertension)

Pregnant females with history of multiple abortions ( two or more abortions)

Pregnant females identified as having twin/triplet pregnancies

Pregnant females not consenting to participate

Pregnant females who are already enrolled in any other study that may interfere with the results of this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm One
Energy dense biscuits will be provided throughout pregnancy after enrolment
Dietary supplement: Energy dense biscuits
Energy dense biscuits will be provided
PLACEBO_COMPARATOR: Arm Two
Wheat Flour,oil, iron and folic acid will be provided fortnightly throughout pregnancy after enrolment
Other: Wheat Flour, oil, iron & Folic acid
Wheat flour, oil, iron and folic acid will be provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal birth weight
Time Frame: within 48 hours of birth
Newborns will be captured within 48 hours of their birth and their birthweight will be measured
within 48 hours of birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal weight gain
Time Frame: on enrolment,20-22 week, 33-35 week of gestation
Maternal weight gain will be assessed by checking maternal weight on all three visits
on enrolment,20-22 week, 33-35 week of gestation
Maternal Hemoglobin and Ferritin
Time Frame: On enrollment and last visit (33-35 weeks of gestation)
Maternal Hemoglobin and Ferritin will be checked by drawing blood on enrollment and on 33-35 weeks of gestation
On enrollment and last visit (33-35 weeks of gestation)
Palatability, acceptability, and compliance of the biscuits
Time Frame: On last visit (33-35 weeks of gestation)
Palatability, acceptability, and compliance of the biscuits by filling a preformed questionnaire
On last visit (33-35 weeks of gestation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

English Biscuit Manufacturers

Investigators

  • Principal Investigator: Farah N Qamar, Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ANTICIPATED)

January 1, 2016

Study Completion (ANTICIPATED)

March 1, 2016

Study Registration Dates

First Submitted

November 5, 2014

First Submitted That Met QC Criteria

November 18, 2014

First Posted (ESTIMATE)

November 19, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 11, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PED 3009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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