FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2014/06/004670 [Registered on: 13/06/2014] Trial Registered Retrospectively
Last Modified On: 11/06/2015
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Vitamin D]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Vitamin D supplementation in Pregnancy 
Scientific Title of Study   A Randomized Controlled Trial to Investigate the Effects of Vitamin D supplementation on maternal and new-born baby’s vitamin D status in Asian-Indian Subjects. 
Trial Acronym  VIDIMAN 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Garima Kachhawa 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Obstetrics and Gynecology AIIMS , New Delhi-29
Department of Obstetrics and Gynecology AIIMS , New Delhi-29
New Delhi
DELHI
110029
India 
Phone  09868398231  
Fax    
Email  garimakachhawa2012@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Garima Kachhawa 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Obstetrics and Gynecology AIIMS , New Delhi-29
Department of Obstetrics and Gynecology AIIMS , New Delhi-29
New Delhi
DELHI
110029
India 
Phone  09868398231  
Fax    
Email  garimakachhawa2012@gmail.com  
 
Details of Contact Person
Public Query  
Name  Garima Kachhawa 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Obstetrics and Gynecology AIIMS , New Delhi-29
Department of Obstetrics and Gynecology AIIMS , New Delhi-29
New Delhi
DELHI
110029
India 
Phone  09868398231  
Fax    
Email  garimakachhawa2012@gmail.com  
 
Source of Monetary or Material Support  
Indian Council of Medical Research (ICMR) 
 
Primary Sponsor  
Name  Indian Council of Medical Research ICMR 
Address  Indian Council of Medical Research P.O. Box No. 4911 Ansari Nagar New Delhi - 110029 India 
Type of Sponsor  Government funding agency 
 
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 
Garima Kachhawa  All India Institute of Medical Sciences  Department of Obstetrics and Gynecology, Room No. 3086 3rd Floor, Teaching Block, AIIMS New Delhi-29
New Delhi
DELHI 		 9868398231

garimakachhawa2012@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Ethics Committee, AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnancy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Vitamin D in dose of 1000 IU/day  Group 1 - subjects will receive 1000 IU of vitamin D per day. Although dose of supplementation has been calculated from daily dose basis, but it will be given, orally as once a month dose (30,000 IU once a month orally,supervised in the hospital), supervised in the hospital till delivery. 
Intervention  Vitamin D in dose of 2000IU/day  Group 2 - subjects will receive 2000 IU of vitamin D per day. Although dose of supplementation has been calculated from daily dose basis, but it will be given, orally as once a month dose (60,000 IU once a month orally,supervised in the hospital) till delivery.  
Intervention  Vitamin D in dose of 4000 IU/day  Group 3 - subjects will receive 4000 IU of vitamin D per day. Although dose of supplementation has been calculated from daily dose basis, but it will be given, orally as once a month dose (120,000 IU once a month orally,supervised in the hospital) till delivery. 
Comparator Agent  Vitamin D in dose of 600 IU/day  Control group - subjects will receive 600 IU of vitamin D per day. Although dose of supplementation has been calculated from daily dose basis, but it will be given, orally as once a month dose (18,000 IU once a month orally,supervised in the hospital) till delivery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  •Pregnant women between 12-16 weeks of gestation.
•Age between 18 to 35 years.
•Subjects agrees for delivery conducted at the AIIMS
 
 
ExclusionCriteria 
Details  Subjects will be excluded from the study if they
•Have more than one gestation in current pregnancy
•Complicated medical or obstetric history that may increase the risk of preterm birth or labor/ delivery complications, based on self-report or clinical assessment by obstetrician (cardiovascular disease, more than three abortions ,hypertension, preeclampsia or Rh isoimmunization)
•Prior history of delivery of an infant with chromosomal abnormalities or IUGR in previous pregnancy
•Presence of any diagnosed systemic disease known to affect vitamin D status such as malabsorption states, liver and renal disorders, primary and tertiary hyperparathyroidism.
•Have features suggestive of osteomalacia or severe VDD.
•Pre-existing hypertension
•Already diagnosed with diabetes (type 1 or 2)
•Are taking or had taken vitamin D supplementation in last two months in doses exceeding 600 IU/day.
•Are using medications known to interact with vitamin D metabolism (steroids,thiazide diuretics, phenytoin, phenobarbitone and antitubercular drugs).
•Have known hypersensitivity to Vitamin D
preparations.
•Have participated in any other investigational drug study in previous three months.
•Have past history of bariatric surgery.
•Are using Ultra-Violet (UV) radiations as a part of medical therapy.
•Are diagnosed with albinism or have other condition associated with decreased skin pigmentation.
•Have any medical condition that in the judgment of the investigator would jeopardize the subject’s safety or evaluation of study drug for efficacy or safety .
Additional exclusion criteria will be applied after biochemical screening:
•Having gestational diabetes between 12-16 weeks of pregnancy.
•Have serum calcium more than 1 mg/dL above the upper limit of normal for age.
•Have serum S.25(OH)D level more than 100 ng/mL.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in vitamin D status of mother and newborn as measured by serum 25 hydroxy vitamin D level   Mother: at start of study, 26-30 week and at the time of delivery; Newborn: cord blood 
 
Secondary Outcome  
Outcome  TimePoints 
1. Weight gain
2. pre-eclampsia
3. Preterm labour
4.Fetal growth
5. New borns Anthropometry
6.Insulin resistance in Mother
7. Insulin resistance in newborn.
 		 1. Wt at recuritment and at delivery
2. After 20 weeks
3. After 24-37 weeks
4.At 28 and 32 week
5. At birth
6. At delivery
7. At birth
 
 
Target Sample Size   Total Sample Size="368"
Sample Size from India="368" 
Final Enrollment numbers achieved (Total)= "351"
Final Enrollment numbers achieved (India)="351" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2014 
Date of Study Completion (India) 31/05/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 31/05/2017 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   No publication yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   In the proposed study, we are planning to investigate the efficacy of three doses of vitamin D supplementation on vitamin D status of mother and newborn at the time of delivery, in comparison to control group who will receive 600 IU per day. Subjects will be randomized into one of the four groups (three intervention groups and one control group), in the ratio of 1:1. 
Subjects in intervention group will receive vitamin D (cholecalciferol) in increasing supplemental doses (Group 1 – 1000 units/day; Group 2 – 2000 units/day; Group 3 - 4000 units per day) while control group will receive 600 units of vitamin D per day. Although dose of supplementation has been calculated from daily dose basis, but it will be given, orally, once a month dose.
Dose of supplementation - Control group will receive 18,000 IU orally once a month while group 1 will receive 30,000 IU per month, group 2 will receive 60,000 IU per month while group 3 will receive 120,000 IU per month. All doses of vitamin D will be given as supervised dose in the hospital (supervised by study staff). Doses of vitamin D will be given till delivery. 

In addition, all study subjects (intervention as well as control group) will also receive 1000 mg of elemental calcium (in two divided doses), similar nutritional and lifestyle advice as part of standard management of pregnancy. After 6-7 months of supplementation, all groups will be compared for primary and secondary outcomes of the study at the time of delivery.

 
Close