Effect of Micronutrients and Life Skills Education on the Health and Nutrition of Adolescent and Young Women in Pakistan

Pregnancy Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03287882
• Other study ID #: 4324-Ped-ERC-16
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: June 30, 2017
• Est. completion date: February 2022

Study information

• Verified date: July 2021
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25447
• Est. completion date: February 2022
• Est. primary completion date: March 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescents
• Anemia
• Empowerment
• Pregnancy

Intervention

Dietary Supplement:
• Multiple micronutrients (UNIMMAP composition)
The intervention is an oral tablet containing 15 different vitamins and minerals at the UNIMMAP composition (includes 30 mg iron, 400 µg folic acid, 15 mg zinc, 2 mg copper, 65 µg selenium, 800 µg RE vitamin A, 1.4 mg vitamin B1, 1.4 mg vitamin B2, 18 mg niacin, 1.9 mg vitamin B6, 2.6 µg vitamin B12, 70 mg vitamin C, 5 µg vitamin D, 10 mg vitamin E and 150 µg iodine). Each tablet is small (approximately 10 mm diameter) and has been procured using the UNICEF supply catalogue. A single MMN supplementation dose will consist of a single tablet.

Behavioral:
• Life skills based education
The life skills based education will be provided bi-monthly in the format of a group session throughout the preconception period. Three topic areas related to empowerment have been prioritized, including preventing early marriage; personal and menstrual hygiene practices; and the importance of nutrition to good health. Integrated within these topics will be messages related to the importance of continuing one's education, mental health, gender norms and equality, decision making, advocacy, resiliency, participation, communication skills, facing challenges, agency, conflict resolution, and the prevention of violence.

Locations

Country	Name	City	State
Pakistan	Matiari Research and Training Centre	Matiari	Sindh

Sponsors (4)

Lead Sponsor	Collaborator
Aga Khan University	Bill and Melinda Gates Foundation, National Program for Family Planning and Primary Health Care, The Hospital for Sick Children

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anemia status	Hemoglobin concentration <12 g/dL	0, 12*, 24 months (*in subgroup only)
Primary	Low birth weight	Birth weight <2500 g	At birth
Secondary	Biomarkers: serum ferritin, serum transferrin receptor, hepcidin, serum retinol, serum 25(OH)D, alpha-glycolytic protein, C-reactive protein (women)		Preconception (subgroup only): enrolment, 1 year, 2 years; Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week
Secondary	Anthropometrics: height (women)		Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months
Secondary	Anthropometrics: middle upper arm circumference (women)		Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months
Secondary	Anthropometrics: weight (women)		Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months
Secondary	Gestational age		At birth
Secondary	Preterm birth		At birth
Secondary	Stillbirth		At birth
Secondary	Small for gestational age		At birth
Secondary	Birth size: length		Within 24 hours of birth
Secondary	Birth size: head circumference		Within 24 hours of birth
Secondary	Birth size: middle upper arm circumference		Within 24 hours of birth
Secondary	Birth size: weight		Within 24 hours of birth
Secondary	Birth defects		At birth
Secondary	Infant growth: length		1, 3, 6, 9, 12 months
Secondary	Infant growth: head circumference		1, 3, 6, 9, 12 months
Secondary	Infant growth: middle upper arm circumference		1, 3, 6, 9, 12 months
Secondary	Infant growth: weight		1, 3, 6, 9, 12 months
Secondary	Age at marriage		Enrolment, 1 year, 2 years
Secondary	Completion of 10th grade education		Enrolment, 1 year, 2 years
Secondary	Use of sanitary pad during last menstrual period		Enrolment, 1 year, 2 years
Secondary	Dietary intake: 24-hour recall (subgroup of women)		Preconception: enrolment; Pregnancy: 4-12 weeks, 32 weeks