Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy- a Dose Comparison Trial

Pregnancy Clinical Trial

Official title:

Assessment of Dose Effectiveness of Vitamin D Supplementation During Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02215213
• Other study ID #: PF8/0911
• Status: Completed
• Phase: N/A
• First received: August 6, 2014
• Last updated: July 15, 2016
• Start date: June 2013
• Est. completion date: January 2016

Study information

• Verified date: July 2016
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Aga Khan University
• Study type: Interventional

Clinical Trial Summary

The study is randomized blinded trial of Vitamin D supplementation to pregnant women; the study participants will receive Vitamin D in supplement form. Pregnant women will be individually randomized to three groups receiving a dose of 400, 2000 and 4000 IU/ day till the time of delivery.A blood sample will also be collected from the participant at the time of recruitment /before the starting of the supplementation for the assessment of Calcium, Phosphorus, Alkaline Phosphatase and Vitamin D levels. The second blood sample for vitamin D level to assess vitamin D status will be done after completion of the supplementation phase at the time of delivery (till 48 hours of delivery). The samples will be sent to Aga Khan University laboratory

Description:

The investigators hypothesize that Pakistani mothers as darkly pigmented, will require substantially higher oral supplementation with vitamin D to replenish the micronutrient stores and aid to resolve associated maternal and neonatal morbidity due to Vitamin D deficiency. The investigators expect that if vitamin D is supplemented to pregnant women, their newborn infants would inevitably replenish the micronutrient stores and aid to resolve the maternal and neonatal morbidity due to Vitamin D deficiency.This is hospital based double blinded trial, study participants divided into three groups which will receive Vitamin D supplementation in 400, 2000 and 4000 International Units. The group which will receive 400 IUs will be treated as control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: January 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pregnant women aged 15 - 45 years

• Less than 16 weeks pregnant from Last menstrual period.

• Agree to take part in this study, will be enrolled.

Exclusion Criteria:

• Pregnant women with pre existing type 1 or type II diabetes,

• Pregnant women with pre existing hypertension

• Women with multiple fetuses, babies (twins, triplets)

• Women with fetal anomaly in scan

• Refuse to participate in the study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pregnancy

Intervention

Drug:
• Vitamin D supplement
comparison of different dosages of vitamin D
• Vitamin D supplement
comparison of different dosages of vitamin D Supplement

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Aga Khan University

Country where clinical trial is conducted

Pakistan, 

References & Publications (4)

Bodnar LM, Catov JM, Roberts JM, Simhan HN. Prepregnancy obesity predicts poor vitamin D status in mothers and their neonates. J Nutr. 2007 Nov;137(11):2437-42. — View Citation

Farrant HJ, Krishnaveni GV, Hill JC, Boucher BJ, Fisher DJ, Noonan K, Osmond C, Veena SR, Fall CH. Vitamin D insufficiency is common in Indian mothers but is not associated with gestational diabetes or variation in newborn size. Eur J Clin Nutr. 2009 May; — View Citation

Gale CR, Robinson SM, Harvey NC, Javaid MK, Jiang B, Martyn CN, Godfrey KM, Cooper C; Princess Anne Hospital Study Group. Maternal vitamin D status during pregnancy and child outcomes. Eur J Clin Nutr. 2008 Jan;62(1):68-77. Epub 2007 Feb 21. — View Citation

Javaid MK, Crozier SR, Harvey NC, Gale CR, Dennison EM, Boucher BJ, Arden NK, Godfrey KM, Cooper C; Princess Anne Hospital Study Group. Maternal vitamin D status during pregnancy and childhood bone mass at age 9 years: a longitudinal study. Lancet. 2006 J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy out come	Hypovitaminosis, Pre eclampsia, Preterm labour, preterm birth, low birth weight, Still birth rates.	At delivery of neonate	No
Secondary	Prevalence of vitamin D deficiency in pregnant women	Maternal vitamin D deficiency in the target group.	at recruitment into study (first trimester)	No