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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04012177
Other study ID # 004-VPT-IRB-18
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 22, 2019
Est. completion date December 31, 2023

Study information

Verified date October 2022
Source Vital Pakistan Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This four arm trial envisions to generate robust evidence for use of a fortified balanced energy-protein supplement to pregnant women for at least 6 months, alone versus in combination of Azithromycin (AZM) prophylaxis (two prophylaxis oral doses) versus in combination with both AZM prophylaxis (two prophylaxis oral doses) plus oral Choline and Nicotinamide supplementation; to see the impact on birth weight and length of newborn soon after birth (approximately within 72 hours). This is an open label, community-based, randomized controlled trial in peri-urban settings of Karachi, Pakistan, where the outcome assessor will be blinded. The comparison groups are control arm (only routine ANC care and nutritional counseling), nutrition only arm, nutrition plus AZM arm, and nutrition plus Choline and Nicotinamide arm.


Description:

Maternal under nutrition has a critical role in etiology of poor perinatal outcomes like low birth weight (LBW), accounting for 60-80% of all neonatal deaths and impacting nearly 20 million newborns overall. In Pakistan, nearly half of the households are food insecure with or without hunger. Great disparities exist between urban-rural and within urban disadvantaged populations living in the poorest of slums. In Sindh province alone, 72% of households are food insecure and 50% are with moderate to severe hunger. Around 18% of the married woman of reproductive age in Pakistan, are underweight and deficient of different micronutrients for example, 42% and 41% of women are Vitamin A and Zinc deficient, respectively.. This impacts childhood stunting, wasting, and underweight, prevalence of which, among under-five children is around 44%, 15% and 31%, respectively in Pakistan. WHO antenatal care (ANC) guidelines recommend the use of fortified balanced energy-protein supplements during pregnancy, but there is a lack of guidance on the best product/supplement for use in a particular setting. Until recently, the WHO ANC guidelines has made no recommendations on the use of these supplements in food insecure and undernourished settings. This is an area that required further research. Additionally, there is emerging literature on use of Choline and Nicotinamide during pregnancy and its potential additional impact on birth outcomes including growth and development after prenatal supplementation with Choline and Nicotinamide. Apart from nutrition supplement, the prophylaxis use of antibiotics, especially AZM is also under strong debate, as many studies have shown improvements in birth outcomes in low middle income settings. The possible mechanism of AZM may be explained through reduction in the risk of maternal infections during pregnancy. A systematic review showed that prophylaxis may reduce the risk of postpartum endometritis, preterm rupture of membranes and gonococcal infection when given routinely to all pregnant women With no effect on birth outcome but there were several biases reported such as high loss to follow-ups and limited numbers of included studies.. Therefore, robust evidence is needed via a field trial in the local context to evaluate the efficacy and effectiveness of the locally-produced, balanced energy-protein supplement alone or in combination with prophylaxis dose of AZM or balanced energy-protein supplement alone or in combination with Choline and Nicotinamide to pregnant woman on maternal and birth outcomes in low-income and food insecure settings. This could help to draw inferences for larger public health policy-making. This investment is specifically aiming to look at what impact a newly formulated nutritional supplement for pregnant and lactating women (PLW) can have on improving birth outcomes and as well as its potential to reduce wasting, stunting and underweight in infants.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1884
Est. completion date December 31, 2023
Est. primary completion date September 5, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 13 Years to 49 Years
Eligibility Inclusion Criteria: - Gestational age between =8 and < 19 weeks confirmed by ultrasound - Able to give written voluntary informed consent. - Permanent resident within the surveillance area, i.e. woman should be resident of the area for last 6 months at least to be considered as part of surveillance. - Willing to spend the whole pregnancy duration after registration in trial within surveillance area until the birth outcome. - Singleton and viable fetus on ultrasound - Not working woman, and available for ANC and compliance visits at home. - Previously not enrolled in pregnant woman trial. - Previously not enrolled in Lactating woman trials. Exclusion Criteria: - Having Mid-upper-arm-circumference of pregnant of =30.5 cm - Having known food allergies if reported by woman (like peanut, lentils)

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Balanced-energy protein (BEP)
Pregnant women in the intervention arms will receive approximately 800 Kcal/day and around 16-21 gram of protein in a day in the form of ready-to-use supplement.
Drug:
Azithromycin Tablets
Pregnant women randomized in Arm C will received two doses of 2000 mg of Azithromycin (4 tablets of 500 mg) oral at week 20 and 28 of pregnancy.
Choline Bitartrate
Pregnant women randomized in Arm D will received 450 mg of Choline orally once daily, starting from week 20 weeks of pregnancy until birth outcome
Nicotinamide
Pregnant women randomized in Arm D will received 100 mg of Nicotinamide orally once daily, starting from week 20 weeks of pregnancy until birth outcome

Locations

Country Name City State
Pakistan Peri-urban slum (Rehri Goth) Karachi Sindh

Sponsors (2)

Lead Sponsor Collaborator
Vital Pakistan Trust Aga Khan University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Other Maternal hemoglobin Assessed in (gm/dl) through Hemocue for all who are agree to assess the difference among four arms At enrollment and 32 weeks of pregnancy
Other Maternal Ferritin level To assess the difference among four arms (ng/ml) At enrollment and 32 weeks of pregnancy
Other Maternal Vitamin D level To assess the difference among four arms (ng/ml) At enrolment and 32 weeks of pregnancy
Other Cord blood Sub-sample - 50 live births in each arm to assess the difference in term of micro- and macro-nutrients and antibodies status. At birth
Other Plasma for proteomic analysis Sub-sample - 50 women in each arm to gain in-depth analysis of proteome which potentially impact (if any) by administration of Azithromycin At week 19 and 32 of pregnancy
Other Plasma for Niacin metabolites Sub-sample - 50 women in each arm to assess the comparison among difference arm to see how these level of metabolites are different among four arm compared to those who received extra daily dose. At enrolment and 32 weeks of pregnancy
Other Urine for Choline metabolites Sub-sample - 50 women in each arm to see how these level of metabolites are different among four arm compared to those who received extra daily dose. At enrolment and 32 weeks of pregnancy
Other Magnetic resonance imaging (MRI) of infants (post birth outcomes) Sub-sample - 50 infants of mothers each arm who will have their birth outcomes to assess brain morphology and volume of infants, using portable MRI machine "Hyperfine". 6 and 12 months of infant's age
Other Global Scale for Early Development assessment Sub-sample - 250 infants of mothers each arm who will have their birth outcomes to assess child neurodevelopment progress, using Global Scale for Early Development (GSED)' tool. Mean scores will be compared between the arms; better scores will predict optimal neurodevelopment according to age. 6 and 12 months of infant's age
Other Mullen assessment Sub-sample - 250 infants of mothers each arm who will have their birth outcomes to assess child neurodevelopment progress, using 'Mullen' tool. Mean scores will be compared between the arms; better scores will predict optimal neurodevelopment according to age. 6 and 12 months of infant's age
Other Hammersmith Neurological Examinations Sub-sample - 250 infants of mothers each arm who will have their birth outcomes to assess child neurodevelopment progress, using 'Hammersmith Neurological Examinations (HINE)' tool. Mean scores will be compared between the arms; better scores will predict optimal neurodevelopment according to age. 6 and 12 months of infant's age
Other Maternal depression Maternal depression will be assessed using Patient Health Questionnaire (PHQ-9) during antenatal period and postnatal period. Depression scarring will be comparing scoring between the arm. Further, we will assess and compare depression severity (in any) from 'None minimal' (0-4 score) to 'Severe' (20-27 score) At week 19 and 32 of pregnancy and then at 6 and 12 month post-partum
Other Maternal and infant stool microbiome Sub-sample - 50 women and the infant in each arm to assess and compared for stool microbiome At week 19 and 32 of pregnancy for mother, and then at 1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
Other Maternal and infant stool Lipocalin-2 Sub-sample - 50 women and the infant in each arm to assess and compared Lipocalin-2 (ng/gm) At week 19 and 32 of pregnancy for mother, and then at 1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
Other Maternal and infant stool Carlprotectin Sub-sample - 50 women and the infant in each arm to assess and compared Carlprotectin (ug/gm) At week 19 and 32 of pregnancy for mother, and then at 1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
Other Maternal and infant stool Myeloperoxidase (MPO) Sub-sample - 50 women and the infant in each arm to assess and compared Myeloperoxidase (ng/ml*dilution factor) At week 19 and 32 of pregnancy for mother, and then at 1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
Other Maternal and infant stool TaqMan assay Sub-sample - 50 women and the infant in each arm to assess and compared different colonies At week 19 and 32 of pregnancy for mother, and then at 1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
Other Maternal and infant stool Bifido species Sub-sample - 50 women and the infant in each arm to assess and compared for Bifido species At week 19 and 32 of pregnancy for mother, and then at 1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
Other Metabolomic work - Maternal during pregnancy All women who are agreed in each arm, for metabolomic work using 'Volumetric Absorptive Microsampling (VAM) At enrolment and 32 week of pregnancy
Other Metabolomic work - Mother-Infant dyad Sub-sample - 50 women and the infant in each arm for metabolomic work using 'Volumetric Absorptive Microsampling (VAM) Infants - sub-sample of 50 infants of same enrolled women in each arm for metabolomic work using'Volumetric Absorptive Microsampling (VAM) 1-2, 3-4 and 5-6 and 12 months post-partum for mother-infant dyad
Other Human milk oligosaccharides Sub-sample - 50 women in each arm to assess and compare breastmilk oligosaccharides within 72 hours of birth
Other Breastmilk quality Sub-sample - 50 women in each arm to assess and compare breastmilk quality (macro-and micro-nutrients) within 72 hours of birth
Other Breastmilk microbiome Sub-sample - 50 women in each arm to assess and compare microbiomes. within 72 hours of birth
Other Breastmilk immunoglobulin Sub-sample - 50 women in each arm to assess immunoglobulins in the breastmilk within 72 hours of birth
Primary Birth weight of newborn Weight of the newborn assess in gram to assess the difference among four arms To be assessed within 72 hours of birth
Secondary Birth length of newborn Length of the newborn assess in cm to assess the difference among four arms To be assessed within 72 hours of birth
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