Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02481375 |
Date of registration:
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10/06/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Is Iron Deficiency the Cause of Anemia Among Women in Cambodia?
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Scientific title:
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Is Iron Deficiency the Cause of Anemia Among Women of Reproductive Age in Cambodia? A 2 x 2 Factorial Double Blind Randomized Controlled Trial of Oral Iron and Multiple Micronutrient Supplementation |
Date of first enrolment:
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July 2015 |
Target sample size:
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809 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02481375 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Diagnostic. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Cambodia
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Contacts
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Name:
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Kroeun Hou, MPH |
Address:
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Telephone:
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Email:
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Affiliation:
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Helen Keller International, Cambodia |
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Name:
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Crystal Karakochuk, MSc, PhD(c) |
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Name:
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Sophonneary Prak, MPH |
Address:
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Telephone:
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Email:
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Affiliation:
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National Maternal and Child Health Center, Ministry of Health, Cambodia |
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Name:
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Tim Green, PhD |
Address:
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Telephone:
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Email:
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Affiliation:
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University of British Columbia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. women between 18-45 years
2. healthy except for Hb = or <117 g/L
3. consent to participate in the study.
Exclusion Criteria:
1. women with Hb >117 g/L
2. women who are currently pregnant
3. women who are taking medications, including any dietary supplements.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Hemoglobin Disorder
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Inflammation
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Iron Deficiency
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Anemia
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Infection
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Intervention(s)
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Dietary Supplement: Multiple micronutrients
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Dietary Supplement: Iron
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Dietary Supplement: Placebo
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Primary Outcome(s)
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Hemoglobin Levels at 12-weeks. Marginal Means (95% CI).
[Time Frame: 12-weeks of intervention]
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Secondary ID(s)
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H15-00933
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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