Clinical trial NCT02294240: Effect of Energy Dense Biscuits in Undernourished Women on Birth Weight of Their Neonates
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Birth Weight
Keywords: Pregnant, malnourished, energy dense biscuits, low birth weight
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: English Biscuit Manufacturers
First posted: 2014-11-19
Enrollment: 224
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neonatal birth weight
timeFrame: within 48 hours of birth
Secondary outcomes:
measure: Maternal weight gain
timeFrame: on enrolment,20-22 week, 33-35 week of gestation
measure: Maternal Hemoglobin and Ferritin
timeFrame: On enrollment and last visit (33-35 weeks of gestation)
measure: Palatability, acceptability, and compliance of the biscuits
timeFrame: On last visit (33-35 weeks of gestation)
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Ali Akbar Shah
state: Sindh
city: Karachi
country: Pakistan
facility: Ibrahim Hyderi
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Farah N Qamar
role: PRINCIPAL_INVESTIGATOR
References:
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