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

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ClinicalTrials.gov Identifier: NCT03287882
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : September 19, 2017
Sponsor:
Collaborators:
The Hospital for Sick Children
National Program for Family Planning and Primary Health Care
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Dr Zulfiqar Ahmed Bhutta, Aga Khan University

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.

Condition or disease Intervention/treatment Phase
Adolescents Anemia Pregnancy Empowerment Dietary Supplement: Multiple micronutrients (UNIMMAP composition) Behavioral: Life skills based education Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Some investigators are blinded to the allocation of the intervention, and all study data collectors are blinded.
Primary Purpose: Prevention
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)
Actual Study Start Date : June 30, 2017
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Weight

Arm Intervention/treatment
No Intervention: Standard of care
  1. Preconception period: none
  2. Pregnancy period: daily iron (60 mg) and folic acid (400 µg) supplementation from confirmation of pregnancy; daily balanced energy protein supplements will additionally be provided to those participants who are underweight at the confirmation of pregnancy for the duration of the pregnancy
  3. Postpartum period: daily iron and folic acid supplementation to 6 months postpartum
Experimental: MMN supplementation and life skills education
  1. Preconception period: twice-weekly MMN supplementation and bi-monthly group session including life skill based education materials
  2. Pregnancy period: daily MMN supplementation from confirmation of pregnancy; daily balanced energy protein supplements will additionally be provided to those participants who are underweight at the confirmation of pregnancy for the duration of the pregnancy
  3. Postpartum period: daily MMN supplementation to 6 months postpartum
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.
Other Name: UNICEF, Micronutrient tabs, pregnancy/PAC-1000

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.




Primary Outcome Measures :
  1. Anemia status [ Time Frame: 0, 12*, 24 months (*in subgroup only) ]
    Hemoglobin concentration <12 g/dL

  2. Low birth weight [ Time Frame: At birth ]
    Birth weight <2500 g


Secondary Outcome Measures :
  1. Biomarkers: serum ferritin, serum transferrin receptor, hepcidin, serum retinol, serum 25(OH)D, alpha-glycolytic protein, C-reactive protein (women) [ Time Frame: Preconception (subgroup only): enrolment, 1 year, 2 years; Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week ]
  2. Anthropometrics: height (women) [ Time Frame: Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months ]
  3. Anthropometrics: middle upper arm circumference (women) [ Time Frame: Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months ]
  4. Anthropometrics: weight (women) [ Time Frame: Preconception: enrolment, 6 months*, 1 year, 2 years (*in subgroup only); Pregnancy: 4-12 weeks, 32 weeks; Postpartum: 1 week, 6 months ]
  5. Gestational age [ Time Frame: At birth ]
  6. Preterm birth [ Time Frame: At birth ]
  7. Stillbirth [ Time Frame: At birth ]
  8. Small for gestational age [ Time Frame: At birth ]
  9. Birth size: length [ Time Frame: Within 24 hours of birth ]
  10. Birth size: head circumference [ Time Frame: Within 24 hours of birth ]
  11. Birth size: middle upper arm circumference [ Time Frame: Within 24 hours of birth ]
  12. Birth size: weight [ Time Frame: Within 24 hours of birth ]
  13. Birth defects [ Time Frame: At birth ]
  14. Infant growth: length [ Time Frame: 1, 3, 6, 9, 12 months ]
  15. Infant growth: head circumference [ Time Frame: 1, 3, 6, 9, 12 months ]
  16. Infant growth: middle upper arm circumference [ Time Frame: 1, 3, 6, 9, 12 months ]
  17. Infant growth: weight [ Time Frame: 1, 3, 6, 9, 12 months ]
  18. Age at marriage [ Time Frame: Enrolment, 1 year, 2 years ]
  19. Completion of 10th grade education [ Time Frame: Enrolment, 1 year, 2 years ]
  20. Use of sanitary pad during last menstrual period [ Time Frame: Enrolment, 1 year, 2 years ]
  21. Dietary intake: 24-hour recall (subgroup of women) [ Time Frame: Preconception: enrolment; Pregnancy: 4-12 weeks, 32 weeks ]


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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287882


Contacts
Contact: Zulfiqar A Bhutta, PhD, MBBS 011922134930051 ext 1054 zulfiqar.bhutta@aku.edu

Locations
Pakistan
Matiari Research and Training Centre Recruiting
Matiari, Sindh, Pakistan
Contact: Zulfiqar A Bhutta, PhD, MBBS    011922134930051 ext 1054      
Sponsors and Collaborators
Aga Khan University
The Hospital for Sick Children
National Program for Family Planning and Primary Health Care
Bill and Melinda Gates Foundation
Investigators
Principal Investigator: Zulfiqar A Bhutta, PhD, MBBS Aga Khan University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Zulfiqar Ahmed Bhutta, Director, Centre of Excellence in Women and Child Health, Aga Khan University
ClinicalTrials.gov Identifier: NCT03287882     History of Changes
Other Study ID Numbers: 4324-Ped-ERC-16
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: September 19, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Zulfiqar Ahmed Bhutta, Aga Khan University:
preconception supplementation
multiple micronutrients
low birth weight

Additional relevant MeSH terms:
Micronutrients
Trace Elements
Growth Substances
Physiological Effects of Drugs