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

Birth Weight Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02294240
• Other study ID #: PED 3009
• Status: Active, not recruiting
• Phase: N/A
• First received: November 5, 2014
• Last updated: January 7, 2016
• Start date: September 2014
• Est. completion date: March 2016

Study information

• Verified date: January 2016
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Aga Khan University Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 224
• Est. completion date: March 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birth Weight
• Body Weight

Intervention

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

Locations

Country	Name	City	State
Pakistan	Ali Akbar Shah	Karachi	Sindh
Pakistan	Ibrahim Hyderi	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
Aga Khan University	English Biscuit Manufacturers

Country where clinical trial is conducted

Pakistan, 

References & Publications (10)

Berghella V. Prevention of recurrent fetal growth restriction. Obstet Gynecol. 2007 Oct;110(4):904-12. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

Kramer MS, Kakuma R. Energy and protein intake in pregnancy. Cochrane Database Syst Rev. 2003;(4):CD000032. Review. Update in: Cochrane Database Syst Rev. 2012;9:CD000032. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal birth weight	Newborns will be captured within 48 hours of their birth and their birthweight will be measured	within 48 hours of birth	No
Secondary	Maternal weight gain	Maternal weight gain will be assessed by checking maternal weight on all three visits	on enrolment,20-22 week, 33-35 week of gestation	No
Secondary	Maternal Hemoglobin and Ferritin	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)	No
Secondary	Palatability, acceptability, and compliance of the biscuits	Palatability, acceptability, and compliance of the biscuits by filling a preformed questionnaire	On last visit (33-35 weeks of gestation)	No