A Phase 3 interventional study of Multiple micronutrients (UNIMMAP composition) and Life skills based education in Adolescents, Anemia and Pregnancy, sponsored by Aga Khan University. Status unknown at 1 site in Pakistan. Open to female participants aged 15 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-27.
Sponsored by Aga Khan University · Phase 3, Interventional, and Prevention
Among 11 studies in Anemia by Aga Khan University — 2 open to participants now, 2 under way, none of them phase 3. Anemia · Aga Khan University.
Among the 11 studies in Anemia by Aga Khan University, this one has the largest enrollment, is the only one that started in 2017, is the only one in phase 3, and was the 6th registered.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
Browse Anemia studies →2 of the 11 studies in Anemia by Aga Khan University are open now, in 1 country. Recruiting first, the newest first:
Aga Khan University · Sites in Pakistan
Ages 26 wk–33 wk · Healthy volunteers
Aga Khan University · Sites in Pakistan
Ages 1 days–59 mo · Healthy volunteers
By country, each count listing its studies:
Of the 122 Anemia studies recruiting now, 67 (55%) set no upper age limit and 37 (30%) stop at 75 or younger; 34 take children under 18; 23 take healthy volunteers.
This study: 15 Years to 24 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 1
First in 2005; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 25,447 is above the median of 117 across 1,336 interventional studies indexed under Anemia.
Median enrollment 610 across the 11 interventional studies. Of the 6 that completed or were terminated, 1 (17%) have results posted.
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Aga Khan University is the lead sponsor of 294 studies on the registry; 43 are open to participants now.
1 of the studies in Anemia by Aga Khan University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07451951Aga Khan UniversityEffectiveness of Small-Quantity vs Medium-Quantity Lipid-Based Nutrient Supplements for Prevention of Undernutrition in Young Children | 2027-07-31 |
Among the 11 studies in Anemia by Aga Khan University, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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Exclusion Criteria:
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
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) · Behavioral: Life skills based education
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.
Also known as: UNICEF, Micronutrient tabs, pregnancy/PAC-1000
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.
Anemia status
Hemoglobin concentration \<12 g/dL
Time frame: 0, 12*, 24 months (*in subgroup only)
Low birth weight
Birth weight \<2500 g
Time frame: At birth
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
Ran from Jun 2017 to primary completion in Mar 2021, 44 months.
Of 52 non-industry phase 3 interventional studies under Anemia, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's 44 months is close to that.
Counting every sponsor, half of 150 studies reached it within 30 months; a quarter within 17 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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