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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: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02481375
Date of registration: 10/06/2015
Prospective Registration: Yes
Primary sponsor: University of British Columbia
Public title: Is Iron Deficiency the Cause of Anemia Among Women in Cambodia?
Scientific title: 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: July 2015
Target sample size: 809
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02481375
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Diagnostic. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Cambodia
Contacts
Name:     Kroeun Hou, MPH
Address: 
Telephone:
Email:
Affiliation:  Helen Keller International, Cambodia
Name:     Crystal Karakochuk, MSc, PhD(c)
Address: 
Telephone:
Email:
Affiliation:  University of British Columbia
Name:     Sophonneary Prak, MPH
Address: 
Telephone:
Email:
Affiliation:  National Maternal and Child Health Center, Ministry of Health, Cambodia
Name:     Tim Green, PhD
Address: 
Telephone:
Email:
Affiliation:  University of British Columbia
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Hemoglobin Disorder
Inflammation
Iron Deficiency
Anemia
Infection
Intervention(s)
Dietary Supplement: Multiple micronutrients
Dietary Supplement: Iron
Dietary Supplement: Placebo
Primary Outcome(s)
Hemoglobin Levels at 12-weeks. Marginal Means (95% CI). [Time Frame: 12-weeks of intervention]
Secondary Outcome(s)
Secondary ID(s)
H15-00933
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Micronutrient Initiative
Helen Keller International
International Development Research Centre, Canada
DSM Nutritional Products, Inc.
Canadian Institutes of Health Research (CIHR)
Ethics review
Results
Results available: Yes
Date Posted: 24/10/2018
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02481375
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