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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 : Unknown
Verified September 2017 by Dr Zulfiqar Ahmed Bhutta, Aga Khan University.
Recruitment status was:  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

Tracking Information
First Submitted Date  ICMJE August 21, 2017
First Posted Date  ICMJE September 19, 2017
Last Update Posted Date September 19, 2017
Actual Study Start Date  ICMJE June 30, 2017
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
  • Anemia status [ Time Frame: 0, 12*, 24 months (*in subgroup only) ]
    Hemoglobin concentration <12 g/dL
  • Low birth weight [ Time Frame: At birth ]
    Birth weight <2500 g
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2017)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Gestational age [ Time Frame: At birth ]
  • Preterm birth [ Time Frame: At birth ]
  • Stillbirth [ Time Frame: At birth ]
  • Small for gestational age [ Time Frame: At birth ]
  • Birth size: length [ Time Frame: Within 24 hours of birth ]
  • Birth size: head circumference [ Time Frame: Within 24 hours of birth ]
  • Birth size: middle upper arm circumference [ Time Frame: Within 24 hours of birth ]
  • Birth size: weight [ Time Frame: Within 24 hours of birth ]
  • Birth defects [ Time Frame: At birth ]
  • Infant growth: length [ Time Frame: 1, 3, 6, 9, 12 months ]
  • Infant growth: head circumference [ Time Frame: 1, 3, 6, 9, 12 months ]
  • Infant growth: middle upper arm circumference [ Time Frame: 1, 3, 6, 9, 12 months ]
  • Infant growth: weight [ Time Frame: 1, 3, 6, 9, 12 months ]
  • Age at marriage [ Time Frame: Enrolment, 1 year, 2 years ]
  • Completion of 10th grade education [ Time Frame: Enrolment, 1 year, 2 years ]
  • Use of sanitary pad during last menstrual period [ Time Frame: Enrolment, 1 year, 2 years ]
  • Dietary intake: 24-hour recall (subgroup of women) [ Time Frame: Preconception: enrolment; Pregnancy: 4-12 weeks, 32 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Micronutrients and Life Skills Education on the Health and Nutrition of Adolescent and Young Women in Pakistan
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE
  • Adolescents
  • Anemia
  • Pregnancy
  • Empowerment
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
    Interventions:
    • Dietary Supplement: Multiple micronutrients (UNIMMAP composition)
    • Behavioral: Life skills based education
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 15, 2017)
25400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03287882
Other Study ID Numbers  ICMJE 4324-Ped-ERC-16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Zulfiqar Ahmed Bhutta, Aga Khan University
Study Sponsor  ICMJE Aga Khan University
Collaborators  ICMJE
  • The Hospital for Sick Children
  • National Program for Family Planning and Primary Health Care
  • Bill and Melinda Gates Foundation
Investigators  ICMJE
Principal Investigator: Zulfiqar A Bhutta, PhD, MBBS Aga Khan University
PRS Account Aga Khan University
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP