A prospective, randomized, open-label, active-controlled, clinical study to evaluate the tolerability and incidence of pregnancy complications up on Lipocal supplementation in pregnant women
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 1. Modified Bovenschen GI Symptoms Questionnaire
Study Overview
Brief Summary
Physiological changes occur in pregnancy and maintaining maternal homeostasis and enabling fetal growth and development have direct association on calcium metabolism. Increased intestinal calcium absorption, increased urine calcium excretion, and increased bone turnover are all part of the calcium homeostatic response during pregnancy. From 6th month onwards, with the third trimester being bulk of calcium utilized, when fetal skeletal growth peaks at 250 to 350 milligrams transferred from pregnant mother and baby every day. Pregnant women’s daily calcium consumption has been reported to be low. WHO recommends 1.5 g to 2 g daily for pregnant women with low dietary calcium intake. Calcium supplementation during pregnancy for women who do not get enough calcium from their diet has a significant benefit in reducing preeclampsia and preterm births, as well as enhancing maternal and child bone health.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 40.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Pregnant females between the ages of ≥18 and 40 years (both inclusive) willing to participate in study and provide written informed consent.
- •Pregnant women at 20th weeks attending antenatal care visit (ANC) visit at study clinics.
Exclusion Criteria
- •No medical contraindications to continuing pregnancy.
- •Treatment with antitubercular and anti-epileptic drugs.
- •History of pre-eclampsia & eclampsia
- •Prior diagnosis of parathyroid disorder or thyroidectomy
- •Diseases that require digoxin, phenytoin, or tetracycline therapy
- •History of chronic liver disease
- •History of renal disease & no known uterine anomaly
- •No history of cervical conization
- •Obesity (BMI 30.0 and higher)
- •Diagnostic history of Type I & Type II Diabetes
- •Diagnostic history of hypertension
- •Subject with multiple pregnancy.
- •Any other condition that in the opinion of the investigator does not justify the patients participation in the study.
Outcomes
Primary Outcomes
1. Modified Bovenschen GI Symptoms Questionnaire
Time Frame: 1. visit 1, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7, visit 8, visit 9. | 2. visit 1, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7, visit 8, visit 9.
2. Tolerability assessed via a five-point Facial Hedonic Scale for
Time Frame: 1. visit 1, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7, visit 8, visit 9. | 2. visit 1, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7, visit 8, visit 9.
Taste (palatability) Swallowability Mouthfeel (texture) & Smell
Time Frame: 1. visit 1, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7, visit 8, visit 9. | 2. visit 1, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7, visit 8, visit 9.
Secondary Outcomes
- Information of any diagnosed preeclampsia during unscheduled ANC visit(visit 1, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7, visit 8 and visit 9.)
- Still birth(Throughout the study)
- Early preterm birth(Start of study and up to 32 weeks)
- Preeclampsia
- Neonatal death(visit 9)
- Perinatal death(visit 6, visit 7, visit 8 and visit 9)
- Bristol Stool Questionnaire(visit 1, visit 2, visit 3, visit 4, visit 5, visit 6, visit 7, visit 8, visit 9)
- Preterm Birth(Throughout the study)
- Placental abruption with grade(Throughout the study)
- IUGR(visit 1, visit 5, visit 6, visit 7, visit 8 and visit 9.)
- Low birth weight(Throughout the study)
- Small for gestational age birth(visit 1, visit 5, visit 6, visit 7, visit 8 and visit 9)