To check how intake of iron rich baby food can help in increasing the level of iron in blood and reduce the risk of iron deficiency.
- Registration Number
- CTRI/2017/02/007767
- Lead Sponsor
- Mr Marc Alder
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 160
1.Age at time of screening of Intervention group should be 6th month of life and Control group should be 12th month of life
2.Apparently healthy
3.Normal weight for age should be within greater or lesser than 2 SD of WHO growth curve
4.Breastfeeding (or formula feeding, or mixed feeding) is already complemented by other foods
5.Having obtained Parent or Legally Acceptable Representative Written Informed Consent
Any of the following criteria would render a subject ineligible for inclusion:
1.Chronic illness necessitating medical follow up
2.Acute ongoing or recent (last 2 weeks) illness necessitating medical follow up
3.Parasitic infection
4.Currently enrolled in a fortification program
5.Documented intolerance to gluten
6.Documented intolerance to lactose
7.Documented allergy to bovine milk proteins
8.Infants with Hemoglobin < 100 g/L and CRP > 10 mg/L
9.Caregivers who are not likely to comply with the study procedures
10.Caregivers that plan to move to another area during the next 6 months (only for the intervention group)
11.Currently participating or having participated in another clinical study during the last 4 weeks prior to the beginning of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The iron status of infants, fed with iron fortified cereal, at 12 months of age will be higher or at least equal to that at baseline (6 months of age) or to that of the observational control group at 12 months of age.Timepoint: Baseline, 6 months age and 12 months age
- Secondary Outcome Measures
Name Time Method To evaluate change in total body iron stores <br/ ><br>To measure inflammatory status by evaluating C-Reactive protein (CRP) <br/ ><br>To evaluate various hematological parameters <br/ ><br>To access normal body development <br/ ><br>To evaluate health status of study subjects for safety assessment during conduct of study <br/ ><br>To assess dietary intake of subject <br/ ><br>To study feeding pattern, parent satisfaction & cost of illness <br/ ><br>To assess developmental status of subject <br/ ><br>Timepoint: Baseline, 6 months age and 12 months age