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.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/02/007767
• Date of registration: 03-02-2017
• Prospective Registration: Yes
• Primary sponsor: Mr Marc Alder
• Public title: 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.
• Scientific title: Effectiveness of iron fortified infant cereals to increase the hemoglobin levels and to reduce the risk of iron-deficiency anemia in infants in India
• Date of first enrolment: 20-03-2017
• Target sample size: 160
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=17088
• Study type: Interventional
• Study design: Other; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr Shariq Anwar
• Affiliation: JSS Medical Research India Private Limited

• Name: Dr Sonika Newar
• Affiliation: JSS Medical Research India Private Limited

Key inclusion & exclusion criteria

Inclusion criteria: 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


Exclusion criteria: 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.



Age minimum:
Age maximum:
Gender:

Intervention(s)

Intervention1: Iron fortified infant cereal: 1. Fortified infant cereal, fortified with micronutrient and constituent with water
2. Daily two servings each of 25 gm of infant cereal reconstituted with 75 ml of lukewarm water in order to provide a puree consistency of cereal.
3. Duration is 6 month
4. Route of administration is oral.

Control Intervention1: NA: NA

Primary Outcome(s)

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(s)

To evaluate change in total body iron stores

To measure inflammatory status by evaluating C-Reactive protein (CRP)

To evaluate various hematological parameters

To access normal body development

To evaluate health status of study subjects for safety assessment during conduct of study

To assess dietary intake of subject

To study feeding pattern, parent satisfaction & cost of illness

To assess developmental status of subject

Timepoint: Baseline, 6 months age and 12 months age

Secondary ID(s)

15.11.INF; 1.0 dated 05 Aug 2016

Source(s) of Monetary Support

Mr. Marc Alder, Project Incharge, Nestec Ltd., Avenue Nestle 55, 1800 Vevey Switzerland

Ethics review

Status: Approved
Approval date: 10/10/2016
Contact:

Institutional Ethics Committee King Goerge Hospital, Vishakhapatnam- 530002, Andhra Pradesh

Status: Approved
Approval date: 03/12/2016
Contact:

Institutional Ethics Committee Deccan College & Medical Sciences & Allied Hospital P.O. Kanchan Bagh DMRLX Road Santosh Nagar Hyderabad

Status: Approved
Approval date: 22/02/2017
Contact:

Institute of Child Hospital 11, Dr. Biresh Guha Street Kolkata-700017

Status: Approved
Approval date: 22/04/2017
Contact:

Institutional Ethics Committee King George Medical University, Office Research Cell, Administration Block King George Medical University, U.P. India

Results

• Date Completed: 18/05/2018