Last updated: 11/03/2018 22:25:58
Investigation of iron uptake from micronutrient fortified powder versus from tailored control in milk
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A double blind, randomized, two-way cross-over study to investigate the uptake of iron from micronutrient fortified powder vs. from tailored control in milk.
Trial description: The present study supplements iron as part of multiple micro-nutrient supplementation to demonstrate that intake of a micronutrient fortified powder in milk helps increase the uptake of key micronutrients like iron due to unique nature of the given matrix, as compared to intake of iron alone in milk.
Primary purpose:
Basic Science
Trial design:
Crossover Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Fractional iron absorption
Timeframe: Day 15
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
25
Primary completion date:
2013-08-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Growth and Development
Product
Not applicable
Collaborators
Not applicable
Study date(s)
February 2013 to March 2013
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
7 - 10 years
Accepts healthy volunteers
Yes
- Demonstrates understanding of the study and willingness to participate as evidenced by participants’ parents and/or legal guardian’s voluntary written informed consent as well as written assent by the participant and has received a signed and dated copy of the informed consent form as well as the assent form
- Participant belonging to middle socio-economic background as per modified Kuppuswamy scale
- Children in Care (CiC)
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds), any of their stated ingredients or any known food allergies like peanut allergy, gluten allergy or lactose intolerance
Inclusion and exclusion criteria
Inclusion criteria:
- Demonstrates understanding of the study and willingness to participate as evidenced by participants’ parents and/or legal guardian’s voluntary written informed consent as well as written assent by the participant and has received a signed and dated copy of the informed consent form as well as the assent form
- Participant belonging to middle socio-economic background as per modified Kuppuswamy scale
- Good general and mental health with, in the opinion of the investigator or medically qualified designee
- Child residing in the peri-urban areas of Bangalore city
- Child with Z-scores of: a. height for age of 0 to ≥-3; b. BMI for age of 0 to ≥-3.
Exclusion criteria:
- Children in Care (CiC)
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds), any of their stated ingredients or any known food allergies like peanut allergy, gluten allergy or lactose intolerance
- Participants with severe anaemia (Haemoglobin < 8g %) as determined by laboratory results
- Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any medical disorder that would make the participant unlikely to fully complete the study or any condition that presents undue risk from the study product or procedures in the opinion of the investigator
- Recent history (3 months) of serious infections, injuries and/ or surgeries
- Children consuming iron, calcium and/or other nutritional supplements and/ or health food drinks on a regular basis (more than 3 times a week) in last 6 months prior to screening visit
- Use of any prescription medications within 15 days prior to screening and throughout the entire duration of the study
- Recent history (within the last 1 year) of alcohol or other substance abuse.
Trial location(s)
Study documents
Statistical analysis plan
Available language(s): English
Clinical study report
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2013-08-03
Actual study completion date
2013-08-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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