NCT02294240

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 19, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

Enrollment Period

1.3 years

First QC Date

November 5, 2014

Last Update Submit

January 7, 2016

Conditions

Birth Weight

Keywords

Pregnant, malnourished, energy dense biscuits, low birth weight

Outcome Measures

Primary Outcomes (1)

  • Neonatal birth weight

    Newborns will be captured within 48 hours of their birth and their birthweight will be measured

    within 48 hours of birth

Secondary Outcomes (3)

  • Maternal weight gain

    on enrolment,20-22 week, 33-35 week of gestation

  • Maternal Hemoglobin and Ferritin

    On enrollment and last visit (33-35 weeks of gestation)

  • Palatability, acceptability, and compliance of the biscuits

    On last visit (33-35 weeks of gestation)

Study Arms (2)

Arm One

EXPERIMENTAL

Energy dense biscuits will be provided throughout pregnancy after enrolment

Dietary Supplement: Energy dense biscuits

Arm Two

PLACEBO COMPARATOR

Wheat Flour,oil, iron and folic acid will be provided fortnightly throughout pregnancy after enrolment

Other: Wheat Flour, oil, iron & Folic acid

Interventions

Energy dense biscuitsDIETARY_SUPPLEMENT

Energy dense biscuits will be provided

Arm One
Wheat Flour, oil, iron & Folic acidOTHER

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

Arm Two

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ali Akbar Shah

Karachi, Sindh, Pakistan

Location

Ibrahim Hyderi

Karachi, Sindh, Pakistan

Location

Related Publications (10)

  • de Onis M, Blossner M, Villar J. Levels and patterns of intrauterine growth retardation in developing countries. Eur J Clin Nutr. 1998 Jan;52 Suppl 1:S5-15.

    PMID: 9511014BACKGROUND

  • Kawai K, Spiegelman D, Shankar AH, Fawzi WW. Maternal multiple micronutrient supplementation and pregnancy outcomes in developing countries: meta-analysis and meta-regression. Bull World Health Organ. 2011 Jun 1;89(6):402-411B. doi: 10.2471/BLT.10.083758. Epub 2011 Mar 21.

    PMID: 21673856BACKGROUND

  • Roberfroid D, Huybregts L, Lanou H, Henry MC, Meda N, Menten J, Kolsteren P; MISAME Study Group. Effects of maternal multiple micronutrient supplementation on fetal growth: a double-blind randomized controlled trial in rural Burkina Faso. Am J Clin Nutr. 2008 Nov;88(5):1330-40. doi: 10.3945/ajcn.2008.26296.

    PMID: 18996870BACKGROUND

  • Berghella V. Prevention of recurrent fetal growth restriction. Obstet Gynecol. 2007 Oct;110(4):904-12. doi: 10.1097/01.AOG.0000267203.55718.aa.

    PMID: 17906027BACKGROUND

  • Ramakrishnan U, Grant FK, Goldenberg T, Bui V, Imdad A, Bhutta ZA. Effect of multiple micronutrient supplementation on pregnancy and infant outcomes: a systematic review. Paediatr Perinat Epidemiol. 2012 Jul;26 Suppl 1:153-67. doi: 10.1111/j.1365-3016.2012.01276.x.

    PMID: 22742608BACKGROUND

  • Osrin D, Vaidya A, Shrestha Y, Baniya RB, Manandhar DS, Adhikari RK, Filteau S, Tomkins A, Costello AM. Effects of antenatal multiple micronutrient supplementation on birthweight and gestational duration in Nepal: double-blind, randomised controlled trial. Lancet. 2005 Mar 12-18;365(9463):955-62. doi: 10.1016/S0140-6736(05)71084-9.

    PMID: 15766997BACKGROUND

  • Gupta P, Ray M, Dua T, Radhakrishnan G, Kumar R, Sachdev HP. Multimicronutrient supplementation for undernourished pregnant women and the birth size of their offspring: a double-blind, randomized, placebo-controlled trial. Arch Pediatr Adolesc Med. 2007 Jan;161(1):58-64. doi: 10.1001/archpedi.161.1.58.

    PMID: 17199068BACKGROUND

  • Jehan I, Harris H, Salat S, Zeb A, Mobeen N, Pasha O, McClure EM, Moore J, Wright LL, Goldenberg RL. Neonatal mortality, risk factors and causes: a prospective population-based cohort study in urban Pakistan. Bull World Health Organ. 2009 Feb;87(2):130-8. doi: 10.2471/blt.08.050963.

    PMID: 19274365BACKGROUND

  • Imdad A, Bhutta ZA. Effect of balanced protein energy supplementation during pregnancy on birth outcomes. BMC Public Health. 2011 Apr 13;11 Suppl 3(Suppl 3):S17. doi: 10.1186/1471-2458-11-S3-S17.

    PMID: 21501434BACKGROUND

  • Kramer MS, Kakuma R. Energy and protein intake in pregnancy. Cochrane Database Syst Rev. 2003;(4):CD000032. doi: 10.1002/14651858.CD000032.

    PMID: 14583907BACKGROUND

MeSH Terms

Conditions

Birth WeightMalnutrition

Interventions

FlourOilsIronFolic Acid

Condition Hierarchy (Ancestors)

Body WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesLipidsMetals, HeavyElementsInorganic ChemicalsTransition ElementsMetalsPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Farah N Qamar

    Aga Khan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 5, 2014

First Posted

November 19, 2014

Study Start

September 1, 2014

Primary Completion

January 1, 2016

Study Completion

March 1, 2016

Last Updated

January 11, 2016

Record last verified: 2016-01

Locations

PA(2)