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CTRI Number  CTRI/2020/12/029778 [Registered on: 14/12/2020] Trial Registered Prospectively
Last Modified On: 11/12/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical study to evaluate Micellar Iron for treatment of Iron Deficiency Anaemia 
Scientific Title of Study   Evaluation of efficacy and safety of Micellar Iron in the treatment of Iron Deficiency Anaemia patients: A prospective, randomised, double-blind, single centre, placebo-controlled, interventional study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
SBS/AWPL/MI/07201 Version 1.0 Date: 11th July 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kiran Chiluka 
Designation  Sr Consultant 
Affiliation  St. Anns Hospital 
Address  Department of General Medicine, St. Anns Hospital, Kazipet, Warangal

Warangal
TELANGANA
506004
India 
Phone  9949382864  
Fax    
Email  drkiranchiluka.krcwgl@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr C M Reddy 
Designation  Chief Scientific Officer 
Affiliation  Amitojas Wellness Private Limited 
Address  #3-100-55/739, Block-A,2nd Floor, JK Arcade Jayaberi Park, Kompally, Hyderabad

Hyderabad
TELANGANA
500014
India 
Phone  8885324455  
Fax    
Email  cso@amitojas.com  
 
Details of Contact Person
Public Query  
Name  Mr Kamal Kammili 
Designation  Director - Operations 
Affiliation  Sanjeevani Bio Services Private Limited 
Address  3rd Floor, Plot No. 28B, Raghavendra Colony, Kondapur, Hyderabad

Hyderabad
TELANGANA
500084
India 
Phone  04048593559  
Fax    
Email  kamal.kammili@sanjeevanibio.com  
 
Source of Monetary or Material Support  
Amitojas Wellness Private Limited 
 
Primary Sponsor  
Name  Amitojas Wellness Private Limited 
Address  2nd Floor, JK Arcade Jayaberi Park, Kompally, Hyderabad, Telangana – 500014, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kiran Chiluka  St Anns Hospital  Department of General Medicine, St. Anns Hospital, Kazipet, Warangal
Warangal
TELANGANA 		 9949382864

drkiranchiluka.krcwgl@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
St. Anns Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D509||Iron deficiency anemia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Micellar Iron Sachets  The investigational product, Micellar Iron is a nutraceutical product, formulated as an edible powder which has Micellar Iron (Ferrous Bisglycinate), vitamin C, Beta Carotene, vitamin B6, vitamin B9, vitamin B12. One sachet of study treatment is to be administered orally once daily for 30 days 
Comparator Agent  Placebo Sachets  The placebo sachets are similar to the Micellar Iron Sachets excpet they do not contain Active Ingredients. One sachet of study treatment is to be administered orally once daily for 30 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Male and female subjects aged 18 years and above.
2. Male subjects with haemoglobin level below 13.0 g/dL and female subjects with haemoglobin level below 12.0 g/dL.
3. Subjects willing to provide informed written consent. 
 
ExclusionCriteria 
Details  1. Pregnant, planning to become pregnant or breastfeeding women.
2. Subjects with anaemia other than iron deficiency anaemia.
3. Subjects have undergone blood transfusion or underwent iron therapy in the last three months.
4. Subjects with microcytic iron-overloading disorder (thalassemia, sideroblastic anemia)
5. Current or past history of a serious illness including, seizures, major psychiatric illness, structural brain disease, liver or kidney failure, organ transplantation, rheumatoid arthritis, uncontrolled hypertension, uncontrolled diabetes or malignancy, cardiovascular event in the last three months.
6. Alcohol or substance abuse
7. Allergy or sensitivity to any of the ingredients in the study treatment
8. Subjects who have participated in other clinical studies during the past 3 months or subjects who intend to participate in other clinical studies parallelly
9. Subjects with any other illness or health condition which in the opinion/medical judgement of the study investigator makes the subject ineligible to participate in the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Serum Ferritin levels documented in the CRF at baseline, and day 30 (values and change from baseline - within the group and between the groups comparisons)  baseline and day 30 
 
Secondary Outcome  
Outcome  TimePoints 
Haemoglobin levels documented in the CRF at baseline, and day 30 (values and change from baseline - within the group and between the groups comparisons)  baseline and day 30 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/12/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Anaemia can be caused by iron deficiency, folate deficiency, vitamin B12 deficiency, and other causes. The term iron deficiency anaemia (IDA) means anaemia that is due to iron deficiency. Iron deficiency anaemia is characterized by the production of small red blood cells. The most common cause of anaemia include nutritional deficiencies, particularly iron deficiency. Iron deficiency anaemia is affiliated with weakness, fatigue, difficulty concentrating, and reduced physical activity, which direct to deterioration in quality of life and productivity of work.
Both in developed and developing countries iron deficiency anaemia is a public health problem affecting about a third of the world’s population. It is noted to appear at all stages of life; children aged 0 to 5 years, women of childbearing age, and pregnant women are particularly at risk. Harmonizing to the World Health Organization report, iron deficiency is the main cause for all the 50% of cases of anaemia. In India the prevalence of any type of anaemia is very high (>95%) among young, adults, and women in gestation. Global Burden of Disease Study 2016, which performed a methodical analysis concluded that, iron-deficiency anaemia was the fourth leading to cause disability in life-style, mostly in women.
Maximum of the adults have at least 3000mg (45mg/Kg) elemental iron in their bodies. Females commonly have decreased levels than males by reason of the iron loss during menses, pregnancies, and lactation. 20mg of iron is recycled daily to manage sufficient supplies of iron for haem synthesis. Accurate diagnosis can play a crucial role in management of IDA. According to WHO, IDA is defined as a level of haemoglobin (Hb) below 13.0 g/dL in male adults, below 12.0 g/dL in female adults who are not pregnant, and below 11.0 g/dL in pregnant women.
Despite the large variety of pharmaceutical products available to treat the iron deficiency anaemia, there are few studies concerning the impact of preventive measurements on nutritional status of iron. Moreover, some of the studies have compared the relative effectiveness of different iron compounds. Among all iron compounds, ferrous sulfate is the mostly recommended iron compound in supplementation because of its low-cost effectiveness. However, it also increases the frequency of gastrointestinal tract adverse effects e.g. nausea, constipation, diarrhea, flatulence, and black stained stools. Besides, bioavailable ferrous sulfate may be decreased by many foods in the gastrointestinal tract which interfere with its absorption leading to variability in the haemoglobin correction during the treatment. Micellar Iron (Ferrous bis-glycinate) has been proposed as an alternative to ferrous sulfate because of its increased bioavailability. Hence, the present study is intended to determine the impact of Micellar Iron on treatment of iron deficiency anaemia.
 
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