Birth WeightNCT02294240
Effect of Energy Dense Biscuits in Undernourished Women on Birth Weight of Their Neonates
A study testing Energy dense biscuits and Wheat Flour, oil, iron & Folic acid in people with Birth Weight, run by Aga Khan University at 2 sites in Pakistan.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Birth Weight
- What is being tested?
- Energy dense biscuits and Wheat Flour, oil, iron & Folic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 2 sitesPakistan
- Study dates
- Sep 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All pregnant females with gestational age ≤14 weeks and Body mass index(BMI) <18.5
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Birth Weight
- Being tested
- Energy dense biscuits, Wheat Flour, oil, iron & Folic acid
- Keywords
- Pregnant, malnourished, energy dense biscuits, low birth weight
- Medical subject headings
- Birth Weight, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy dense biscuitsDietary supplement
Energy dense biscuits will be provided
Wheat Flour, oil, iron & Folic acidOther
Wheat flour, oil, iron and folic acid will be provided
| Study group | Role | What they receive |
|---|---|---|
| Arm One | Experimental | Energy dense biscuits will be provided throughout pregnancy after enrolment Receives: Dietary Supplement: Energy dense biscuits |
| Arm Two | Placebo comparator | Wheat Flour,oil, iron and folic acid will be provided fortnightly throughout pregnancy after enrolment Receives: Other: Wheat Flour, oil, iron & Folic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal birth weight
Newborns will be captured within 48 hours of their birth and their birthweight will be measured
Measured: within 48 hours of birth
Secondary outcomes (3)
Maternal weight gain
Maternal weight gain will be assessed by checking maternal weight on all three visits
Measured: on enrolment,20-22 week, 33-35 week of gestation
Maternal Hemoglobin and Ferritin
Maternal Hemoglobin and Ferritin will be checked by drawing blood on enrollment and on 33-35 weeks of gestation
Measured: On enrollment and last visit (33-35 weeks of gestation)
Palatability, acceptability, and compliance of the biscuits
Palatability, acceptability, and compliance of the biscuits by filling a preformed questionnaire
Measured: On last visit (33-35 weeks of gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionJan 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Birth WeightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- English Biscuit Manufacturers
- Responsible party
- Principal investigator, Dr Faraz Naz Qamar, Aga Khan University
- Investigators
- Farah N Qamar, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02294240
- Sponsor's protocol ID
- PED 3009
- Status last verified
- Jan 2016
- First submitted
- 5 Nov 2014
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9511014Kawai 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.
PubMed 21673856Roberfroid 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.
PubMed 18996870Berghella V. Prevention of recurrent fetal growth restriction. Obstet Gynecol. 2007 Oct;110(4):904-12. doi: 10.1097/01.AOG.0000267203.55718.aa.
PubMed 17906027Ramakrishnan 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.
PubMed 22742608Osrin 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.
PubMed 15766997Gupta 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.
PubMed 17199068Jehan 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.
PubMed 19274365Imdad 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.
PubMed 21501434Kramer MS, Kakuma R. Energy and protein intake in pregnancy. Cochrane Database Syst Rev. 2003;(4):CD000032. doi: 10.1002/14651858.CD000032.
PubMed 14583907
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02294240
- Acronym / sponsor ID
- PED 3009
- Conditions
- Birth Weight
- Keywords
- Pregnant, malnourished, energy dense biscuits, low birth weight
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- English Biscuit Manufacturers
- Study start
- Sep 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 19 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm One | Experimental | Dietary Supplement: Energy dense biscuitsEnergy dense biscuits will be provided throughout pregnancy after enrolment |
| Arm Two | Placebo comparator | Other: Wheat Flour, oil, iron & Folic acidWheat Flour,oil, iron and folic acid will be provided fortnightly throughout pregnancy after enrolment |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All pregnant females with gestational age ≤14 weeks and Body mass index(BMI) <18.5
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy dense biscuitsEnergy dense biscuits will be provided | Dietary supplement | Arm One |
| Wheat Flour, oil, iron & Folic acidWheat flour, oil, iron and folic acid will be provided | Other | Arm Two |
Primary outcome
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
3 secondary outcomes
Maternal weight gain
Time frame: 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)
Palatability, acceptability, and compliance of the biscuits
Time frame: On last visit (33-35 weeks of gestation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
- Background: PubMed 9511014de 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.
- Background: PubMed 21673856Kawai 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.
- Background: PubMed 18996870Roberfroid 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.
- Background: PubMed 17906027Berghella V. Prevention of recurrent fetal growth restriction. Obstet Gynecol. 2007 Oct;110(4):904-12. doi: 10.1097/01.AOG.0000267203.55718.aa.
- Background: PubMed 22742608Ramakrishnan 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.
- Background: PubMed 15766997Osrin 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.
- Background: PubMed 17199068Gupta 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.
- Background: PubMed 19274365Jehan 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.
- Background: PubMed 21501434Imdad 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.
- Background: PubMed 14583907Kramer MS, Kakuma R. Energy and protein intake in pregnancy. Cochrane Database Syst Rev. 2003;(4):CD000032. doi: 10.1002/14651858.CD000032.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farah N Qamar principal investigator
Aga Khan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy dense biscuits and Wheat Flour, oil, iron & Folic acid in people with Birth Weight, run by Aga Khan University at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal birth weight (time frame: within 48 hours of birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02294240, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2016.