Effect of Energy Dense Biscuits in Undernourished Women on Birth Weight of Their Neonates
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Neonatal birth weight [within 48 hours of birth]
Newborns will be captured within 48 hours of their birth and their birthweight will be measured
Secondary Outcome Measures
- Maternal weight gain [on enrolment,20-22 week, 33-35 week of gestation]
Maternal weight gain will be assessed by checking maternal weight on all three visits
- Maternal Hemoglobin and Ferritin [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
- Palatability, acceptability, and compliance of the biscuits [On last visit (33-35 weeks of gestation)]
Palatability, acceptability, and compliance of the biscuits by filling a preformed questionnaire
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ali Akbar Shah | Karachi | Sindh | Pakistan | |
| 2 | Ibrahim Hyderi | Karachi | Sindh | Pakistan |
Sponsors and Collaborators
- Aga Khan University
- English Biscuit Manufacturers
Investigators
- Principal Investigator: Farah N Qamar, Aga Khan University
Study Documents (Full-Text)
None provided.More Information
Publications
- Berghella V. Prevention of recurrent fetal growth restriction. Obstet Gynecol. 2007 Oct;110(4):904-12.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- PED 3009