Clinical trial NCT03287882: Effect of Micronutrients and Life Skills Education on the Health and Nutrition of Adolescent and Young Women in Pakistan
Official title: Prospective, Cluster Randomized Effectiveness Trial of Multiple Micronutrient Supplementation and Life Skills Education Provided From Preconception on Health and Nutrition Outcomes of Young, Reproductive-age Pakistani Women (15-24 Years)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Adolescents
Anemia
Pregnancy
Empowerment
Keywords: preconception supplementation
multiple micronutrients
low birth weight
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
name: National Program for Family Planning and Primary Health Care
name: Bill and Melinda Gates Foundation
First posted: 2017-09-19
Enrollment: 25447
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary aims of this study are: 1) To evaluate the impact of supplementation with multiple micronutrients (MMN) from preconception and life skills education among women 15-18.9 years of age at enrolment on the prevalence of anemia in a population setting; and 2) To evaluate the impact of supplementation with MMN from preconception and life skills education among young women 15-24 years of age on the rate of low birth weight (LBW) in a population setting. Infants born to mothers enrolled in the study will be followed for 1 year. This study aims to enrol 25,400 non-pregnant young women in Matiari district. This sample size is anticipated to equate to 1456 births. Participants will be randomized by cluster to receive either MMN supplements and life skills education or the standard of care at enrolment. Clusters have been defined based on health facility catchment areas. MMN supplements will be provided twice weekly during the preconception period, once daily during the pregnancy period, and once daily until 6 months after giving birth during the postpartum period; and a package of life skills education materials will be provided bi-monthly during the preconception period. In addition to the primary outcomes, measurements will include micronutrient status, anthropometrics, birth outcomes, dietary intake and feeding practices, adherence, and indices of empowerment.


Eligibility criteria: Inclusion Criteria:

* Minimum age at enrolment: 15 years
* Maximum age at enrolment: 23 years
* Any marital status
* Intend to comply with study intervention and follow up

Exclusion Criteria:

* Women participating in other nutrition trials
* Women who intend to leave the study area
* Women who are already pregnant

Primary outcomes:
measure: Anemia status
timeFrame: 0, 12*, 24 months (*in subgroup only)
measure: Low birth weight
timeFrame: At birth
Secondary outcomes:
measure: Biomarkers: serum ferritin, serum transferrin receptor, hepcidin, serum retinol, serum 25(OH)D, alpha-glycolytic protein, C-reactive protein (women)
timeFrame: Preconception (subgroup only): enrolment, 1 year, 2 years; Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week
measure: Anthropometrics: height (women)
timeFrame: Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months
measure: Anthropometrics: middle upper arm circumference (women)
timeFrame: Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months
measure: Anthropometrics: weight (women)
timeFrame: Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months
measure: Gestational age
timeFrame: At birth
measure: Preterm birth
timeFrame: At birth
measure: Stillbirth
timeFrame: At birth
measure: Small for gestational age
timeFrame: At birth
measure: Birth size: length
timeFrame: Within 24 hours of birth
measure: Birth size: head circumference
timeFrame: Within 24 hours of birth
measure: Birth size: middle upper arm circumference
timeFrame: Within 24 hours of birth
measure: Birth size: weight
timeFrame: Within 24 hours of birth
measure: Birth defects
timeFrame: At birth
measure: Infant growth: length
timeFrame: 1, 3, 6, 9, 12 months
measure: Infant growth: head circumference
timeFrame: 1, 3, 6, 9, 12 months
measure: Infant growth: middle upper arm circumference
timeFrame: 1, 3, 6, 9, 12 months
measure: Infant growth: weight
timeFrame: 1, 3, 6, 9, 12 months
measure: Age at marriage
timeFrame: Enrolment, 1 year, 2 years
measure: Completion of 10th grade education
timeFrame: Enrolment, 1 year, 2 years
measure: Use of sanitary pad during last menstrual period
timeFrame: Enrolment, 1 year, 2 years
measure: Dietary intake: 24-hour recall (subgroup of women)
timeFrame: Preconception: enrolment; Pregnancy: 4-12 weeks, 32 weeks
Other outcomes:
Locations:
city: Matiari
country: Pakistan
facility: Matiari Research and Training Centre
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Zulfiqar A Bhutta, PhD, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baxter JB, Kortenaar JL, Wasan Y, Hussain A, Soofi SB, Ahmed I, Bhutta ZA. Age-Based Anthropometric Cutoffs Provide Inconsistent Estimates of Undernutrition: Findings from a Cross-Sectional Assessment of Late-Adolescent and Young Women in Rural Pakistan. Curr Dev Nutr. 2021 Nov 10;5(11):nzab130. doi: 10.1093/cdn/nzab130. eCollection 2021 Nov.
citation: Bhutta ZA. Reply to NF Krebs and KM Hambidge. Am J Clin Nutr. 2019 Aug 1;110(2):521-522. doi: 10.1093/ajcn/nqz078. No abstract available.
citation: Bhutta ZA. Balancing the benefits of maternal nutritional interventions; time to put women first! Am J Clin Nutr. 2019 Feb 1;109(2):249-250. doi: 10.1093/ajcn/nqy336. No abstract available.
citation: Baxter JB, Wasan Y, Soofi SB, Suhag Z, Bhutta ZA. Effect of life skills building education and micronutrient supplements provided from preconception versus the standard of care on low birth weight births among adolescent and young Pakistani women (15-24 years): a prospective, population-based cluster-randomized trial. Reprod Health. 2018 May 31;15(1):104. doi: 10.1186/s12978-018-0545-0.
citation: Baxter JB, Wasan Y, Soofi SB, Suhag Z, Bhutta ZA. Feasibility and effect of life skills building education and multiple micronutrient supplements versus the standard of care on anemia among non-pregnant adolescent and young Pakistani women (15-24 years): a prospective, population-based cluster-randomized trial. Reprod Health. 2018 May 30;15(1):103. doi: 10.1186/s12978-018-0547-y.